Titan Inflatable Penile Prosthesis (IPP)
FDA premarket approval P000006/S064 · decided 2023-03-03
Approval details
- PMA number
- P000006
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Titan Inflatable Penile Prosthesis (IPP)
- Generic name
- Device, impotence, mechanical/hydraulic
- Applicant
- Coloplast Corp.
- Date received
- 2022-12-05
- Decision date
- 2023-03-03
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- FHW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for changes to the packaging to include new or modified components in the prosthesis assembly kits and to reorganize the packaging of these assembly kits, and changes to the instructions for use to accommodate the new assembly kits as well as reorganization of content.
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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 |