|
Device | ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S186 |
Date Received | 03/06/2009 |
Decision Date | 04/03/2009 |
Product Code |
LWS |
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 AUTOMATE THE MANUFACTURING PROCESS FOR THE INSERT-MOLDED BOND PAD ARRAY COMPONENT. |