K994240 is an FDA 510(k) clearance for the EX 45-BP, MODEL 330 132. 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 April 13, 2000, 119 days after receiving the submission on December 16, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K994240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | December 16, 1999 |
| Decision Date | April 13, 2000 |
| Days to Decision | 119 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 |