|
Device | OVATIO CRT |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P060027 |
Supplement Number | S003 |
Date Received | 06/23/2008 |
Decision Date | 07/23/2008 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING PROCESS CHANGES ENHANCING THE QUALITY CONTROLS PERTAINING TO SYMPHONY AND RHAPSODY PACEMAKERS AS WELL AS OVATIO ICD AND CRT-D SYSTEM DEVICES. |