|
Device | OVATIO VR AND OVATIO DR ICDS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S051 |
Date Received | 11/16/2009 |
Decision Date | 12/14/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE IN THE LOCATION FOR MANUFACTURING THE HYBRID ELECTRONIC MODULE COMPONENT. |