The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Sorin Biomedica Orion 30/a Cardiac Stimulator & Pm.
Device ID | K851365 |
510k Number | K851365 |
Device Name: | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM |
Classification | Implantable Pacemaker Pulse-generator |
Applicant | SORIN BIOMEDICA, FIAT, USA, INC. JEANNE-MARIE VARGA 375 PARK AVENUE New York, NY 10152 |
Contact | Jeanne-marie Varga |
Correspondent | Jeanne-marie Varga SORIN BIOMEDICA, FIAT, USA, INC. JEANNE-MARIE VARGA 375 PARK AVENUE New York, NY 10152 |
Product Code | DXY |
CFR Regulation Number | 870.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-05 |
Decision Date | 1985-12-03 |