|
Device | FORTIFY AND VARIOUS FAMILIES OF CURRENT |
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 | S202 |
Date Received | 09/12/2011 |
Decision Date | 11/01/2011 |
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 INTRODUCTION OF THE IS4/DF4 PORT PLUG ACCESSORY MODEL AC-IS4PP FOR USE WITH ALL SJM DF4 OR IS4 HEADER PORTS. |