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 |