|
Device | SECURA DR/VR/VIRTUOSO DR/VR ICD/MAXIMO II DR/VR/VIRTUOSO II VR/DR |
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 | S213 |
Date Received | 11/27/2009 |
Decision Date | 12/23/2009 |
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 IMPLEMENTATION OF RADIO FREQUENCY DEVICE TEST CHANGES ON THE AUTOMATED TEST EQUIPMENT APPLICATION SOFTWARE. |