The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for A1-a,abp,b,mbp, Lead Connectors; Peh Adapter Sleeve.
| Device ID | K970388 |
| 510k Number | K970388 |
| Device Name: | A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE |
| Classification | Pacemaker Lead Adaptor |
| 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 | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-08-14 |
| Summary: | summary |