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 | ATS OPEN PIVOT BILEAFLET |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC ATS MEDICAL, INC. 3800 ANNAPOLIS LANE, SUITE 175 PLYMOUTH, MN 55447 |
PMA Number | P990046 |
Supplement Number | S006 |
Date Received | 05/01/2002 |
Decision Date | 05/29/2002 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO TRANSFER THE MANUFACTURING OF THE PYROLYTIC CARBON COATED HEART VALVE COMPONENTS FROM SULZER CARBOMEDICS, INC., TO ATS MEDICAL INC., MINNEAPOLIS, MINNESOTA. |
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