|
Device | SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S078 |
Date Received | 02/29/2012 |
Decision Date | 03/21/2012 |
Withdrawal Date
|
05/07/2018 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS. |