SALINE-FILLED TESTICULAR PROSTHESIS
FDA premarket approval P020003/S003 · decided 2004-07-28
Approval details
- PMA number
- P020003
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SALINE-FILLED TESTICULAR PROSTHESIS
- Generic name
- Prosthesis, testicular
- Applicant
- Coloplast Corp.
- Date received
- 2004-07-13
- Decision date
- 2004-07-28
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- FAF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL TO ADD A CAUTIONARY STATEMENT TO THE OUTER PACKAGING SPECIFYING THAT THE DEVICE SHOULD BE FILLED WITH SALINE PRIOR TO IMPLANTATION.
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