Submission Details
| 510(k) Number | K933055 FDA.gov |
| FDA Decision | Not Cleared PT (PT) |
| Date Received | May 27, 1993 |
| Decision Date | May 02, 1994 |
| Days to Decision | 340 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Not Cleared
Traditional
K933055 - MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF (FDA 510(k) Clearance)
May 1994
Decision
340d
Days
Class 3
Risk
K933055 is an FDA 510(k) submission for the MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Not Cleared (DENG) decision on May 2, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
Device Classification
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |