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 | Coloplast Saline-Filled Testicular Prosthesis (Torosa) |
Generic Name | Prosthesis, testicular |
Regulation Number | 876.3750 |
Applicant | COLOPLAST CORP. 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 |
PMA Number | P020003 |
Supplement Number | S011 |
Date Received | 08/17/2022 |
Decision Date | 09/16/2022 |
Product Code |
FAF |
Advisory Committee |
Gastroenterology/Urology |
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 a size inspection step for the Torosa Saline Filled Testicular Prosthesis (SFTP) during manufacturing. |
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