PMA P990075S022
- Device
- SALINE-FILLED & SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S022
- Product code
- FWM
- Decision date
- 2013-10-08
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- APPROVAL FOR UPDATED LABELING INCORPORATING INFORMATION ON ANAPLASTIC LARGE CELL LYMPHOMA (ALCL).
Current openFDA PMA Record#
- Device
- SALINE-FILLED & SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S022
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2013-10-08
- Decision code
- APPR
- Date received
- 2011-02-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED LABELING INCORPORATING INFORMATION ON ANAPLASTIC LARGE CELL LYMPHOMA (ALCL).