COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
FDA premarket approval P000006/S009 · decided 2008-05-23
Approval details
- PMA number
- P000006
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Trade name
- COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2008-03-11
- Decision date
- 2008-05-23
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A CHANGE OF ACCELERATED AGING TEMPERATURE FROM 65 DEGREES C TO 60 DEGREES C IN A STABILITY PROTOCOL FOR THE DEVICE.
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