The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for S80 Implantable Cardiac Pacing Lead.
| Device ID | K854963 |
| 510k Number | K854963 |
| Device Name: | S80 IMPLANTABLE CARDIAC PACING LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | SORIN BIOMEDICA, FIAT, USA, INC. VIA CRESCENTINO 13040 SALUGGIA (VC) Italy, IT |
| Contact | Maria Varga |
| Correspondent | Maria Varga SORIN BIOMEDICA, FIAT, USA, INC. VIA CRESCENTINO 13040 SALUGGIA (VC) Italy, IT |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-11 |
| Decision Date | 1986-06-24 |