TITAN INFLATABLE PENILE PROSTHESIS
FDA premarket approval P000006/S013 · decided 2008-12-22
Approval details
- PMA number
- P000006
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TITAN INFLATABLE PENILE PROSTHESIS
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2008-11-24
- Decision date
- 2008-12-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- USE OF A NEW METHOD FOR MARKING THE SALINE FILLED TESTICULAR PROSTHESIS AND THE TITAN INFLATABLE PENILE PROSTHESIS AND FOR BORING SUTURE HOLES ON THE TITAN INFLATABLE PENILE PROSTHESIS.
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