The following data is part of a premarket notification filed by Pacesetter, Inc. with the FDA for Tendril, Unipolar Endocardial Screw-in Lead.
| Device ID | K951087 |
| 510k Number | K951087 |
| Device Name: | TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar, CA 91342 -3577 |
| Contact | Paul Mason |
| Correspondent | Paul Mason PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar, CA 91342 -3577 |
| 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 | 1995-03-09 |
| Decision Date | 1995-06-29 |