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 | VARIOUS FAMILIES OF CURRENT, ATLAS, EPIC, CONVERT, CURRENT, & FORTIFY ICD'S |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S291 |
Date Received | 02/22/2012 |
Decision Date | 04/13/2012 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS. |
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