TITAN INFLATABLE PENILE PROSTHESIS
FDA premarket approval P000006/S040 · decided 2015-04-13
Approval details
- PMA number
- P000006
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TITAN INFLATABLE PENILE PROSTHESIS
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2015-01-27
- Decision date
- 2015-04-13
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR CHANGES IN THE LABELING OF THE TITAN INFLATABLE PENILE PROSTHESIS SURGICAL PROTOCOL TO INCORPORATE ECTOPIC PLACEMENT.
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510(k) clearances by this applicant
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|---|---|---|
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| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |