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 | CADENCE ICDS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S145 |
Date Received | 07/19/2007 |
Decision Date | 08/17/2007 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ALTERNATE SUPPLIER FOR THE DIODE DIE, SILICON, 20V, 5%, ZENAR VOLTAGE REGULATORY, AND THE DIODE DIE, HIGH VOLTAGE, HIGH CURRENT COMPONENTS FOR THE DEVICE. |
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