MENTOR SALINE-FILLED MAMMARY PROSTHESES
FDA premarket approval P990075/S002 · decided 2000-12-22
Approval details
- PMA number
- P990075
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MENTOR SALINE-FILLED MAMMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2000-10-23
- Decision date
- 2000-12-22
- Days to decision
- 60 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR AN INCREASED SHELL THICKNESS OF THE CONTOUR TALL PROFILE STYLES 5000, 5000PT, 6000, AND 6000PT.
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