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 | TREO Abdominal Stent-Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Bolton Medical Inc. 799 International Pkwy Sunrise, FL 33325 |
PMA Number | P190015 |
Supplement Number | S008 |
Date Received | 11/24/2020 |
Decision Date | 12/17/2020 |
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 a change to the nylon sub-supplier, the anti-block additive used, and the extrusion process used in the manufacturing of the product pouches for the Treo Abdominal Stent-Graft System and the Relay Thoracic Stent-Graft with Plus Delivery System |
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