COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
FDA premarket approval P020003 · decided 2002-07-19
Approval details
- PMA number
- P020003
- Trade name
- COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
- Generic name
- Prosthesis, testicular
- Applicant
- Coloplast Corp.
- Date received
- 2002-01-22
- Decision date
- 2002-07-19
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- FAF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- Yes
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE MENTOR SALINE-FILLED TESTICULAR PROSTHESIS. THE DEVICE IS INDICATED FOR USE WHEN COSMETIC TESTICULAR REPLACEMENT IS INDICATED; I.E., IN THE CASE OF AGENESIS OR FOLLOWING THE SURGICAL REMOVAL OF A TESTICLE.
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510(k) clearances by this applicant
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|---|---|---|
| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
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| 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 |
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| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |