|
Device | PARADYM VR AND DR, PARADYM RF VR AND DR |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S081 |
Date Received | 02/25/2013 |
Decision Date | 03/26/2013 |
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 CHANGES TO THE PROCESS LIMITS FOR GASES USED TO FILL FINISHED DEVICES AND ALSO UPDATES TO THE GAS CONCENTRATION LIMITS WITHIN THE INTERNAL ATMOSPHERE FOR THE IMPLANTABLE PULSE GENERATORS. |