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 | HANCOCK I LOW POROSITY AND MIDIFIED ORIFICE VALVED CONDUIT MODEL 105 |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC HEART VALVES 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P790007 |
Supplement Number | S030 |
Date Received | 07/28/2011 |
Decision Date | 08/25/2011 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADDITION OF A GLUTARALDEHYDE SUPPLIER. |
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