|
Device | GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S006 |
Date Received | 01/06/2006 |
Decision Date | 03/02/2006 |
Product Code |
NKE |
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 MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER. |