|
Device | ENTRUST; INTRINSIC; MARQUIS; ONYX; SECURA; VARIOUS FAMILIES OF GEM, MAXIMO, PROTECTA, & VIRTUOSO |
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 | S321 |
Date Received | 09/13/2011 |
Decision Date | 10/31/2011 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS. |