MENTOR TITAN INFLATABLE PENILE PROSTHESIS
FDA premarket approval P000006/S002 · decided 2003-01-14
Approval details
- PMA number
- P000006
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MENTOR TITAN INFLATABLE PENILE PROSTHESIS
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2002-08-07
- Decision date
- 2003-01-14
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR REPROCESSING FINAL, STERILIZED ALPHA I INFLATABLE PENILE PROSTHESES TO INCORPORATE THE HYDROPHILIC COATING THAT WAS PREVIOUSLY APPROVED FOR USE ON NEWLY MANUFACTURED PROSTHESES IN SUPPLEMENT 1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR TITAN INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
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510(k) clearances by this applicant
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|---|---|---|
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| Luja Coude (K241210) | Coloplast Corp. | 2024-11-21 |
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