Submission Details
| 510(k) Number | K023205 FDA.gov |
| FDA Decision | Cleared ST |
| Date Received | September 25, 2002 |
| Decision Date | April 24, 2003 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Traditional
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
Apr 2003
Decision
211d
Days
Class 3
Risk
About This 510(k) Submission
K023205 is an FDA 510(k) clearance for the ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP, 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 24, 2003, 211 days after receiving the submission on September 25, 2002. This device falls under the Cardiovascular 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 |
Manufacturer
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