The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Retrox Rx 45-jbp 124774, 53-jbp 124775, 53-bp 124776, 60-124777.
| Device ID | K990483 |
| 510k Number | K990483 |
| Device Name: | RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-16 |
| Decision Date | 1999-06-03 |
| Summary: | summary |