|
Device | PARADYM VR/DR AND PARADYM RF VR/DR ICD'S |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S079 |
Date Received | 02/11/2013 |
Decision Date | 03/12/2013 |
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 NEW AUTOMATED OPTICAL INSPECTION EQUIPMENT TO BE USED DURING THE MICRO ELECTRONIC PROCESS. |