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 | REPLY PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S032 |
Date Received | 11/09/2007 |
Decision Date | 07/25/2008 |
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 REPLY SR/DR PACEMAKER MODELS AND SMARTVIEW 2.08UG1 PROGRAMMING SOFTWARE MANUFACTURED BY SORIN BIOMEDICA CRM, S.R.L., SALUGGIA (VC) ITALY. |
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