The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Tir/tij And Polyrox.
| Device ID | K972500 |
| 510k Number | K972500 |
| Device Name: | TIR/TIJ AND POLYROX |
| 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 Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1998-03-04 |
| Summary: | summary |