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 | ENTRUST ICD FAMILY |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S166 |
Date Received | 04/22/2010 |
Decision Date | 10/19/2010 |
Product Codes |
LWS 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 MODIFICATIONS TO THE MEDTRONIC ENRHYTHM PULSE GENERATORS AND ENTRUST (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) PROGRAMMER APPLICATION SOFTWARE MODEL 9987 (VERSION 7.2), MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) (PART OF MODEL 2490G CARELINK MONITOR SYSTEM), FIRMWARE, AND THE POST STERILIZATION MANUFACTURING TEST SOFTWARE. |
Approval Order | Approval Order |
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