The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Bipolar Implantable Endocardial Pacing Leads, With Silicone Rubber Insulation And Passive Fixation.
| Device ID | K964604 |
| 510k Number | K964604 |
| Device Name: | BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Joseph J Schwoebel, Rac |
| Correspondent | Joseph J Schwoebel, Rac BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-18 |
| Decision Date | 1997-03-10 |
| Summary: | summary |