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 | S008 |
Date Received | 07/28/2006 |
Decision Date | 09/29/2006 |
Withdrawal Date
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01/28/2022 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN SUPPLIERS FOR A POLYTETRAFLUOURETHYLENE (PTFE) ROD USED IN THE MANUFACTURE OF THE DEVICE. |
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