PMA P990075S021
- Device
- MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S021
- Product code
- FWM
- Decision date
- 2009-03-31
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- APPROVAL FOR REVISED LABELING THAT REFLECTS 10-YEAR POST-APPROVAL STUDY DATA.
Current openFDA PMA Record#
- Device
- MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S021
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2009-03-31
- Decision code
- APPR
- Date received
- 2008-04-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED LABELING THAT REFLECTS 10-YEAR POST-APPROVAL STUDY DATA.