PMA P990075S006
- Device
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S006
- Decision date
- 2001-08-09
- Approval order statement
- APPROVAL FOR LAL TESTING TO BE DONE ON A SKIP LOT AUDIT BASIS EVERY SIX MONTHS.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S006
- Decision date
- 2001-08-09
- Decision code
- APPR
- Date received
- 2001-07-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR LAL TESTING TO BE DONE ON A SKIP LOT AUDIT BASIS EVERY SIX MONTHS.