|
Device | PARADYM VR 8750, PARADYM DR8750 |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S083 |
Date Received | 07/15/2013 |
Decision Date | 08/13/2013 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF NON-FUNCTIONAL STRUCTURES WITHIN THE METAL LAYERS AND THEMODIFICATION OF THE VISUAL INSPECTION PROCESS FOR INTEGRATED CIRCUITS IN THE IMPLANTABLE PULSE GENERATORS. |