Minix 8340, 8341, 8342 Minix-St 8330, 8331
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K884215 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MINIX 8340, 8341, 8342 and MINIX-ST 8330, 8331 are implantable pacemaker pulse generators, designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. These devices are classified as Class III medical devices under FDA regulations, requiring stringent pre-market approval due to their critical role in managing cardiac conditions.
These pulse generators are intended for surgical implantation and are supplied sterile for single-use. They are regulated under FDA 510(k) clearance (K884215) and fall under the product code DXY, adhering to the regulation number 870.3610. Each model number corresponds to specific variations in functionality or programming, ensuring compatibility with various pacemaker systems for cardiovascular applications.
Frequently asked questions
Are these pacemaker pulse generators designed for reuse or single-use, and how does that affect their handling in the operating room?
The MINIX 8340, 8341, 8342, and MINIX-ST 8330, 8331 are supplied sterile for single-use only. This means each device is intended to be implanted once and discarded afterward, eliminating the need for sterilization between uses. Clinicians should follow sterile technique protocols during implantation to ensure patient safety, as reuse is not supported by the manufacturer.
What are the key differences between the MINIX 8340/8341/8342 models and the MINIX-ST 8330/8331 models, and how might that impact clinical selection?
The MINIX 8340, 8341, and 8342 models, as well as the MINIX-ST 8330 and 8331 models, represent functional or programming variations tailored to specific pacemaker systems. While exact differences aren’t detailed in the data, the ‘ST’ designation in the MINIX-ST models may imply specialized features (e.g., biventricular support or pacing algorithms). Clinicians should consult Medtronic’s documentation to confirm compatibility with their existing pacing leads and patient needs before selection.
How should these devices be stored prior to implantation, and what are the implications of improper storage?
The MINIX pulse generators are sterile upon packaging, so they must be stored in their original, unopened packaging to maintain sterility. Exposure to moisture, extreme temperatures, or physical damage could compromise sterility or functionality. Facilities should adhere to Medtronic’s storage guidelines—typically room temperature (15–30°C) and protected from direct sunlight—to preserve device integrity until use.
What regulatory pathway was followed for FDA clearance of these devices, and what does that mean for clinicians or purchasers?
These devices received FDA 510(k) clearance (K884215) under the product code DXY, classified as Class III due to their role in managing life-sustaining cardiac functions. The clearance was determined ‘Substantially Equivalent’ (SESE) by the FDA’s Cardiovascular (CV) Advisory Committee, meaning they meet the same performance standards as a predicate device. Clinicians or purchasers can rely on this pathway to confirm the device’s compliance with U.S. regulations for implantable pacemakers.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884215 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K884215 24 fields · synced Oct 6, 2026