Biotronik, Inc. · Class III · Cleared Mar 10, 1997
| K-number | K964604 |
| Device name | BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION |
| Applicant | Biotronik, Inc. |
| Product code | DTB |
| Device class | Class III |
| Decision date | Mar 10, 1997 |
| Decision | Substantially Equivalent - Subject to Tracking & PMS |
| Regulation | 870.3680 |
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