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 | ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600,KAPPA 650,KAPPA 700,KAPPA 800,KAPPA 900, RELIA,SENSIA,SIGMA, VERSA |
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 | S431 |
Date Received | 07/02/2015 |
Decision Date | 08/17/2015 |
Product Code |
NVZ |
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 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986. |
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