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 | RX Herculink Elite Renal and Biliary Stent System |
Generic Name | STENT, RENAL |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110001 |
Supplement Number | S020 |
Date Received | 05/15/2023 |
Decision Date | 06/14/2023 |
Product Code |
NIN |
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 Alternative sourcing of raw materials for one of the adhesives. |
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