|
Device | MICRONY/REGENCY AND FRONTIER |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S020 |
Date Received | 12/20/2005 |
Decision Date | 03/02/2006 |
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 MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER. |