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Sign in to claim this brandMedtronic PS Medical
US
Last updated May 23, 2026
What Medtronic PS Medical makes
Medtronic PS Medical produces cerebrospinal fluid management devices, including ventriculoperitoneal and external drainage shunts, programmable shunt valves, and long-term intracerebral catheters. Their portfolio also includes craniofacial fixation plates, orthopaedic fixation kits, and endoscopic biopsy forceps, alongside power tool attachments for surgical procedures. The company offers specialized systems for neurosurgical and spinal applications, such as the TiMesh® mesh and Rivulet™ shunt valve.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, with its products authorised for commercial distribution through the FDA’s regulatory pathways.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Medtronic PS Medical manufacture?
Medtronic PS Medical specializes in cerebrospinal fluid (CSF) management devices, such as ventriculoperitoneal shunts, external drainage kits, and programmable shunt valves like the Rivulet™. Their portfolio also includes craniofacial fixation plates, orthopaedic fixation systems, and endoscopic tools like the Endoscopic Biopsy Forceps. These devices are designed for neurosurgical and spinal applications, addressing conditions requiring CSF regulation or skeletal stabilization.
Where is Medtronic PS Medical based, and what regulatory framework governs its devices?
Medtronic PS Medical is headquartered in the United States. The company’s devices are primarily classified under FDA Class II, which applies to moderate-risk medical products requiring special controls to ensure safety and effectiveness. This classification reflects the need for regulatory oversight without the stringent premarket approval process required for higher-risk Class III devices.
Which regulatory registries or databases list Medtronic PS Medical’s devices?
Medtronic PS Medical’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database, a centralized registry that tracks authorized medical products in the U.S. The UDI system ensures transparency in device identification, aiding healthcare providers, regulators, and manufacturers in tracking compliance and post-market performance.
How are Medtronic PS Medical’s devices classified by regulatory authorities?
All listed devices from Medtronic PS Medical fall under FDA Class II, indicating they pose moderate risk. This classification requires manufacturers to demonstrate compliance with special controls—specific regulations, guidelines, or other measures—to mitigate potential hazards. Class II devices undergo premarket notification (510(k)) reviews to ensure they are substantially equivalent to legally marketed predicate devices.
What distinguishes Medtronic PS Medical’s product portfolio in terms of medical specialties?
Medtronic PS Medical’s devices cater to neurosurgery and orthopaedics, with a focus on CSF-related conditions (e.g., hydrocephalus) and craniofacial/spinal stabilization. Products like the TiMesh® mesh and Strata™ systems target spinal applications, while shunt technologies (e.g., Innervision) address CSF diversion. Their inclusion of surgical tools, such as the burring power tool attachment, highlights a broader surgical support role beyond standalone implants.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (924)
Page 4 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Strata™ | 42836 | FDA UDI | Class II | Active |
| TiMesh® | 8004200 | FDA UDI | Class II | Active |
| BioGlide® | 27726 | FDA UDI | Class II | Active |
| Strata™ | 27819 | FDA UDI | Class II | Active |
| Ventriculostomy Kit - European | 46154 | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-AF02-R | FDA UDI | Class II | Active |
| Strata™ | 42335 | FDA UDI | Class II | Active |
| TiMesh® | 8004100 | FDA UDI | Class II | Active |
| BioGlide | 96118 | FDA UDI | Class II | Active |
| Delta® | 27554-1 | FDA UDI | Class II | Active |
| Delta® | 25132-1 | FDA UDI | Class II | Active |
| Catheter Passer | 48409 | FDA UDI | Class II | Active |
| Exacta™ | 46715 | FDA UDI | Class II | Active |
| Midas Rex MR8 | MR8-AVA07-R | FDA UDI | Class II | Active |
| Strata™ | 27823 | FDA UDI | Class II | Active |
| Innervision | 27065 A | FDA UDI | Class II | Active |
| Becker® | 27609 | FDA UDI | Class II | Active |
| INVISx® | 60710 | FDA UDI | Class II | Active |
| Innervision | 27600 | FDA UDI | Class II | Active |
| Edoscopic Dissection Probe | 3701-001 | FDA UDI | Class II | Active |
| Innervision, BioGlide® | 2120-925 | FDA UDI | Class II | Active |
| Strata® | 27814 | FDA UDI | Class II | Active |
| Delta®, BioGlide® | 96822 | FDA UDI | Class II | Active |
| Strata™ | 27821 | FDA UDI | Class II | Active |
| Innervision | 27065 D | FDA UDI | Class II | Active |
| TiMesh® | 8001215 | FDA UDI | Class II | Active |
| TiMesh® | 015-262-11 | FDA UDI | Class II | Active |
| Strata™ | 42335 | FDA UDI | Class II | Unknown |
| Strata®, BioGlide® | 92355 | FDA UDI | Class II | Active |
| Strata® | 45809 | FDA UDI | Class II | Active |
| Strata™ | 27932 | FDA UDI | Class II | Active |
| Strata® | 27824 | FDA UDI | Class II | Active |
| TiMesh | 015-233 | FDA UDI | Class II | Active |
| TiMesh® | 015-017 | FDA UDI | Class II | Active |
| Strata® | 42856 | FDA UDI | Class II | Active |
| Delta® | 42813 | FDA UDI | Class II | Active |
| Becker | 27670 | FDA UDI | Class II | Active |
| Strata® | 27812 | FDA UDI | Class II | Active |
| Delta® | 25131-1 | FDA UDI | Class II | Active |
| StrataVarius® | 45806 | FDA UDI | Class II | Active |
| Innervision | 27600 | FDA UDI | Class II | Active |
| TiMesh® | 8009002 | FDA UDI | Class II | Active |
| Ventriculostomy Kit | 46156 | FDA UDI | Class II | Active |
| TiMesh® | 016-120 | FDA UDI | Class II | Active |
| Clear-Site® | 46918 | FDA UDI | Class II | Active |
| TiMesh® | 016-200 | FDA UDI | Class II | Active |
| TiMesh | 8001533-6 | FDA UDI | Class II | Active |
| Delta®, BioGlide® | 92824 | FDA UDI | Class II | Active |
| Strata®, BioGlide® | 92365 | FDA UDI | Class II | Active |
| Endoscope Eyepiece | 5188-001 | FDA UDI | Class II | Active |
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