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 | MICRONY II SR MODEL 2525T/MICRONY K SR MODEL 2535K PULSE GENERATORS |
Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P970013 |
Supplement Number | S001 |
Date Received | 03/13/2001 |
Decision Date | 04/30/2001 |
Product Code |
LWO |
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 MICRONY II SR+ MODEL 2525T AND MICRONY K SR MODEL 2535K PULSE GENERATORS. |
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