K990483 is an FDA 510(k) clearance for the RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on June 3, 1999, 107 days after receiving the submission on February 16, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K990483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | February 16, 1999 |
| Decision Date | June 03, 1999 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |