HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000
FDA premarket approval P990075/S003 · decided 2001-06-18
Approval details
- PMA number
- P990075
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2001-05-14
- Decision date
- 2001-06-18
- Days to decision
- 35 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR THE HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000.
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