MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
FDA premarket approval P020003/S001 · decided 2003-02-05
Approval details
- PMA number
- P020003
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
- Generic name
- Prosthesis, testicular
- Applicant
- Coloplast Corp.
- Date received
- 2002-11-07
- Decision date
- 2003-02-05
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- FAF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR REVISION OF THE POSTAPPROVAL STUDY PROTOCOL TO DISCONTINUE THE REQUIREMENT FOR BLOOD COLLECTION AT THE 5-YEAR EXAM.
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