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 | MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC CARDIAC SURGERY 8299 CENTRAL AVE., N.E. SPRING LAKE PARK, MN 55432-3576 |
PMA Number | P790018 |
Supplement Number | S043 |
Date Received | 03/22/2002 |
Decision Date | 04/09/2002 |
Withdrawal Date
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12/23/2011 |
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 FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC, SPRING LAKE PARK, MINNESOTA. MANUFACTURING OPERATIONS RELATED TO FABRICATION OF THE SEWING RING, ATTACHMENT OF THE CONDUIT AND SEWING RING TO THE DISC AND HOUSING SUBASSEMBLY, AND STERILE AND FINAL PACKAGING PROCESSES FOR THE MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT PROSTHESIS (MODEL R7700) WILL BE PERFORMED AT THIS FACILITY. |
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