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 | TITAN INFLATABLE PENILE PROSTHESIS |
Generic Name | device, impotence, mechanical/hydraulic |
Regulation Number | 876.3350 |
Applicant |
COLOPLAST CORP. |
1601 west river road north |
minneapolis, MN 55411 |
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PMA Number | P000006 |
Supplement Number | S045 |
Date Received | 09/21/2015 |
Decision Date | 11/23/2015 |
Product Code |
FHW
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Advisory Committee |
Gastroenterology/Urology |
Supplement Type | real-time process |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
APPROVAL FOR CHANGES TO THE HYDROPHILIC COATING SPECIFICATIONS AND MANUFACTURING PROCESS. |
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