The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Px 53/15-bp, Model 130 050 And Px 60/15-bp, Model 130 051.
| Device ID | K000763 |
| 510k Number | K000763 |
| Device Name: | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, GMBH & CO. 6024 JEAN RD. Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, GMBH & CO. 6024 JEAN RD. Lake Oswego, OR 97035 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-09 |
| Decision Date | 2000-04-06 |