Titan Inflatable Penile Prosthesis
FDA premarket approval P000006/S059 · decided 2021-01-08
Approval details
- PMA number
- P000006
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Titan Inflatable Penile Prosthesis
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2020-12-09
- Decision date
- 2021-01-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Change in the spring supplier and manufacturing process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| Luja Coudé (K251116) | Coloplast Corp. | 2025-06-27 |
| Luja Set (K250270) | Coloplast Corp. | 2025-04-17 |
| SureCath Set (K242049) | Coloplast Corp. | 2024-11-26 |
| Luja Coude (K241210) | Coloplast Corp. | 2024-11-21 |
| Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (K242173) | Coloplast Corp. | 2024-11-12 |
| Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (K242473) | Coloplast Corp. | 2024-10-18 |
| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |