Titan Inflatable Penile Prosthesis
FDA premarket approval P000006/S075 · decided 2026-07-20
Approval details
- PMA number
- P000006
- Supplement
- S075
- 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
- 2026-06-18
- Decision date
- 2026-07-20
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- approval to incorporate a lot release strategy into the manufacturing process for the kink-resistant tubing
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |