Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S171 |
Date Received | 10/22/2009 |
Decision Date | 03/25/2011 |
Product Code |
NVZ |
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 APPROVAL FOR PROTECTA XT CRT-D D314TRG AND PROTECTA CRT-D D334TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, AND PROTECTA VR D334VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODEL SW009 APPLICATION SOFTWARE V1.0, CARELINK MONITOR MODEL 2490C UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE. |
Approval Order | Approval Order |
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