|
Device | PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S314 |
Date Received | 06/11/2012 |
Decision Date | 09/10/2012 |
Product Codes |
LWS NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement PROTECTA CRT-D MODEL D334TRG; PROTECTA DF4 CRT-D MODEL 334TRM: PROTECTA XTCRT-D MODEL D314TRG; AND PROTECTA XT DF4 CRT-D MODEL D314TRM. |