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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceTorosa Saline Filled Testicular Prosthesis
Generic NameProsthesis, testicular
Regulation Number876.3750
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP020003
Supplement NumberS012
Date Received06/05/2026
Decision Date07/21/2026
Product Code FAF 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to increase the amount of manufacturing cleanroom space by converting existing space into a new cleanroom, along with installing a deionized water system and clean dry air system in the cleanroom
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