COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
FDA premarket approval P000006/S007 · decided 2008-06-13
Approval details
- PMA number
- P000006
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2006-08-16
- Decision date
- 2008-06-13
- Days to decision
- 667 days
- Decision code
- APPR
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR: 1) REVISION OF THE CURRENT TITAN PROSTHESIS TO INCLUDE A NEW ONE-TOUCH RELEASE PUMP BODY; 2) ADDITION OF NUSIL TECHNOLOGY MED-4755 SILICONE AS AN OPTIONAL ALTERNATIVE TO THE CURRENTLY USED NUSIL TECHNOLOGY MED-4515 AND MED-4750 SILICONES; 3) ADDITION OF A 1.5CM REAR TIP EXTENDER IN THE TITAN ASSEMBLY KITS; 4) ADDITION OF A SPECIFICATION IMPOSING A LOWER LIMIT OF 2.5 LB FOR TACTILE FORCE FOR DEFLATION USING THE OTR PUMP; AND 5) LABELING REVISIONS RELATING TO THE ABOVE DEVICE CHANGES
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