SALINE FILLED TESTICULAR PROSTHESIS
FDA premarket approval P020003/S006 · decided 2008-12-22
Approval details
- PMA number
- P020003
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SALINE FILLED TESTICULAR PROSTHESIS
- Generic name
- Prosthesis, testicular
- Applicant
- Coloplast Corp.
- Date received
- 2008-11-24
- Decision date
- 2008-12-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- FAF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- USE OF A NEW METHOD FOR MARKING THE SALINE FILLED TESTICULAR PROSTHESIS AND THE TITAN INFLATABLE PENILE PROSTHESIS AND FOR BORING SUTURE HOLES ON THE TITAN INFLATABLE PENILE PROSTHESIS.
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 |