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 | KAPPA 900 (MODEL 9988 V8.0). ADAPTA, VERSA, SENSIA (MODEL SW003 V8.0), RELIA (MODEL SW010 V8.0), ENPULSE (MODEL 9981 V8. |
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 | S280 |
Date Received | 07/17/2012 |
Decision Date | 03/13/2013 |
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 THE KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPA 900, ADAPTA, SENSIA, RELIA, ENPULSE, ENRHYTHM, ADVISA, VERSA AND SIGMA. |
Approval Order | Approval Order |
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