MENTOR SALINE-FILLED BREAST IMPLANTS
FDA premarket approval P990075/S006 · decided 2001-08-09
Approval details
- PMA number
- P990075
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2001-07-26
- Decision date
- 2001-08-09
- Days to decision
- 14 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR LAL TESTING TO BE DONE ON A SKIP LOT AUDIT BASIS EVERY SIX MONTHS.
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