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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.
 
DeviceTitan Inflatable Penile Prosthesis
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberP000006
Supplement NumberS046
Date Received02/22/2017
Decision Date05/17/2017
Product Code FHW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition of a new insertion tool; update of pusher tool design; addition of shods supplied with kit; modification of package layout and material; use of new package denesting agent; and 2 year and 5 year shelf-life protocol.
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