The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Elc 35-up Model Number 116015 And Elc 54-up Model Number 115606.
| Device ID | K965106 |
| 510k Number | K965106 |
| Device Name: | ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Joseph J Schwoebel |
| Correspondent | Joseph J Schwoebel 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 | 1996-12-20 |
| Decision Date | 1998-01-27 |
| Summary: | summary |