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 | RelayPro Stent-Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Bolton Medical, Inc. 799 International Parkway Sunrise, FL 33325 |
PMA Number | P200045 |
Supplement Number | S011 |
Date Received | 03/18/2024 |
Decision Date | 04/17/2024 |
Product Code |
MIH |
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 implementation of alternate sub-suppliers used in the manufacturing of the sutures used on the Relay Pro, Relay Plus, and TREO Stent Graft Systems |
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