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 | MEDTRONIC RELIA IMPLANTABLE PULSE GENERATOR AND MODEL SW010APPLICATION SOFTWARE |
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 | S097 |
Date Received | 06/02/2008 |
Decision Date | 11/26/2008 |
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 |
Approval Order Statement APPROVAL FOR THE MEDTRONIC RELIA SERIES OF PULSE GENERATORS WHICH ARE RATE RESPONSIVE, MULTI-PROGRAMMABLE, SINGLE AND DUAL CHAMBER DEVICES (MODELS REDR01, RED01, REVDD01, RESR01, RES01) AND THE ASSOCIATED SW010 APPLICATIONS SOFTWARE (VERSION 1.0). |
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