|
Device | ANTHEM FAMILY OF CRT-P DEVICES |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S116 |
Date Received | 01/24/2014 |
Decision Date | 03/31/2014 |
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 A MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS. |