COLOPLAST SALINE-FILLED TESTICULAR IMPLANT
FDA premarket approval P020003/S005 · decided 2007-10-09
Approval details
- PMA number
- P020003
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLOPLAST SALINE-FILLED TESTICULAR IMPLANT
- Generic name
- Prosthesis, testicular
- Applicant
- Coloplast Corp.
- Date received
- 2007-07-23
- Decision date
- 2007-10-09
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- FAF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO REPORT POST APPROVAL STUDY RESULTS.
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