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 | STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120 |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P870038 |
Supplement Number | S005 |
Date Received | 02/11/2005 |
Decision Date | 07/20/2005 |
Withdrawal Date
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01/28/2022 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE SUPPLIER OF POLYETHYLENE TETRAFLUOROETHYLENE (PTFE) THREAD, NAMELY W.L. GORE, AND FOR A CHANGE FROM MULTIFILAMENT PTFE THREAD TO MONOFILAMENT PTFE THREAD USED IN THE FINAL SEWING OF THE CLOTH TO COMPLETE THE SEWING RING OF THE STARR-EDWARDS SILASTIC BALL PROSTHESIS, MODELS 1260 & 6120. |
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