Submission Details
| 510(k) Number | K953866 FDA.gov |
| FDA Decision | Cleared ST |
| Date Received | August 10, 1995 |
| Decision Date | December 15, 1995 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Traditional
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
Dec 1995
Decision
127d
Days
Class 3
Risk
About This 510(k) Submission
K953866 is an FDA 510(k) clearance for the MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION), a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 15, 1995, 127 days after receiving the submission on August 10, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.
Device Classification
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III — Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |
Manufacturer
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