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 | Closer Vascular Sealing System (VSS) |
Generic Name | Device, hemostasis, vascular |
Applicant | REX MEDICAL, L.P. 555 E. NORTH LANE SUITE 5035 CONSHOHOCKEN, PA 19428 |
PMA Number | P150022 |
Supplement Number | S007 |
Date Received | 09/11/2018 |
Decision Date | 10/01/2018 |
Product Code |
MGB |
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 Addition of an alternate vendor for the tipping process. |
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