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 PROSTHETIC HEART VALVE |
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 | S034 |
Date Received | 10/27/1998 |
Decision Date | 11/16/1998 |
Withdrawal Date
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12/23/2011 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-day notice requested a change in the supplier of a raw material (yarn) for the device because the current supplier of Polytetrafluoroethylene (PTFE) yarn has chosen to withdraw this material from the implantable medical device industry. |
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