Identity
- Trade Name
- Prometra Programmable Pump FDA UDI
- Generic Name
- Implantable intrathecal infusion pump, programmable FDA UDI
- Device Name
- The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. FDA UDI
- Model / Reference
- 11827 FDA UDI
- Description
- The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810335020082 FDA UDI
- PMA Number
- P080012 FDA UDI
- FDA Product Code
- LKK FDA UDI
- GMDN Term
- Implantable intrathecal infusion pump, programmable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Implantable intrathecal infusion pump, programmable
Prometra Programmable Pump by Flowonix Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable intrathecal infusion pump, programmable.
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- SYNCHROMED® II — MEDTRONIC, INC. · Class III
- SYNCHROMED ® II — MEDTRONIC, INC. · Class III
- SYNCHROMED® II — MEDTRONIC, INC. · Class III
- SynchroMed® II — MEDTRONIC, INC. · Class III
- SYNCHROMED® II — MEDTRONIC, INC. · Class III
- SYNCHROMED™ III — MEDTRONIC, INC. · Class III
- SYNCHROMED®II — MEDTRONIC, INC. · Class III
Cleared under the same submission
P080012 also covers:
- Prometra Catheter Access Kit — Flowonix Medical, Inc.
- Prometra Catheter Revision Kit — Flowonix Medical, Inc.
- Prometra Clinical Programmer — Flowonix Medical, Inc.
- Prometra Clinician Programmer Print Tool — Flowonix Medical, Inc.
- Prometra II Pump — Flowonix Medical, Inc.
- Prometra Intrathecal Catheter — Flowonix Medical, Inc.
- Prometra Patient Therapy Controller — Flowonix Medical, Inc.
- Prometra Physician Configuration Device — Flowonix Medical, Inc.
- Prometra Programmable Pump — Flowonix Medical, Inc.
- Prometra Programmer — Flowonix Medical, Inc.
- Prometra Programmer — Flowonix Medical, Inc.
- Prometra Refill Kit — Flowonix Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Flowonix Medical, Inc.
Sources (1)
- FDA UDI e09049d7-8a0f-4939-8708-743af0a54551 35 fields · synced May 30, 2026