|
Device | MERLIN PATIENT CARE SYSTEM MODEL 3650 |
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 | S008 |
Date Received | 04/18/2005 |
Decision Date | 10/12/2005 |
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 MERLIN PATIENT CARE SYSTEM WITH THE MODEL 3330 VERSION 1.0 SOFTWARE. |