PMA P990075S005
- Device
- MENTOR SALINE-FILLED MAMMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S005
- Product code
- FWM
- Decision date
- 2001-10-31
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- APPROVAL FOR REVISED PATIENT LABELING THAT INCORPORATES THE RESULTS OF THE FOCUS GROUP STUDY.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED MAMMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S005
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2001-10-31
- Decision code
- APPR
- Date received
- 2001-07-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED PATIENT LABELING THAT INCORPORATES THE RESULTS OF THE FOCUS GROUP STUDY.