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 | INSYNC III |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S031 |
Date Received | 07/26/2007 |
Decision Date | 09/18/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE TO THE XM485 AND XM486 WIRE BOND TERMINAL BLOCKS FOUND IN MEDTRONIC KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA, SIGMA, 350 SERIES, THERA/PRODIGY, KAPPA 400, AND INSYNC-II IMPLANTABLE PULSE GENERATOR AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILIES. |
Post-Approval Study | Show Report Schedule and Study Progress |
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