|
Device | SMARTVIEW hotspot; Orchestra Plus Link |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S126 |
Date Received | 07/07/2017 |
Decision Date | 07/27/2017 |
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 a rework process for components used in the SMARTVIEW hotspot and the Orchestra Plus Link peripheral devices. |