The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Retrox Rx 53-bp, Retrox Rx 60-bp, Retrox Rx 45-jbp, Retrox Rx 53-jbp Model Numbers 124 396, 124 397, 124 395, 124 000.
| Device ID | K981083 |
| 510k Number | K981083 |
| Device Name: | RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Lauren L Foote Christensen |
| Correspondent | Lauren L Foote Christensen 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 | 1998-03-24 |
| Decision Date | 1998-07-22 |
| Summary: | summary |