|
Device | REPLY/ESPRIT SR AND DR MODEL PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S079 |
Date Received | 04/30/2013 |
Decision Date | 06/20/2013 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE FLEX CIRCUIT HYBRID COMPONENT AND APPRFOR AN ALTERNATE SUPPLIER. |
Approval Order | Approval Order |