Medtronic Minix & Minix St Pulse Generators
510(k) K930770
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930770 | Date14 May 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Medtronic Minix and Minix ST Pulse Generators are implantable pacemaker pulse-generators designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are intended for patients requiring temporary or permanent pacing support to manage bradycardia or other conduction disorders, ensuring consistent and reliable cardiac output.
These pulse generators are supplied sterile and intended for single-use implantation, adhering to Class III regulatory requirements under FDA 510(k) clearance (K930770). They are classified under product code DXY and manufactured by Medtronic Vascular. Storage and handling must comply with sterile medical device protocols, and their use is governed by FDA-authorized clinical indications for pacemaker therapy.