ALPHA I INFLATABLE PENILE PROSTHESIS
FDA premarket approval P000006/S001 · decided 2002-06-14
Approval details
- PMA number
- P000006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALPHA I INFLATABLE PENILE PROSTHESIS
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2001-05-17
- Decision date
- 2002-06-14
- Days to decision
- 393 days
- Decision code
- APPR
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR HYDROPHILIC COATING OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR ALPHA 1 INFLATABLE PENILE PROSTHESIS WITH HYDROPHILIC COATING AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
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