PMA P990075S016
- Device
- SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S016
- Product code
- FWM
- Decision date
- 2005-07-27
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- APPROVAL FOR 1) NEW STYLE 2000 MODERATE PLUS PROFILE, WHICH IS CONSIDERED A MODIFICATION TO THE EXISTING PRODUCT INE, WITH SIZES 175CC-800CC; 2) ADDITIONAL SIZES OF 400CC, 450CC, 500CC, 600CC, 650CC AND 800CC FOR STYLE 1600; AND 3) ADDITIONAL SIZES OF 350CC, 400CC, 700CC, 770CC, AND 800CC FOR STYLE 3000. THERE ARE NO CHANGES TO THE INDICATIONS FOR USE.
Current openFDA PMA Record#
- Device
- SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S016
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2005-07-27
- Decision code
- APPR
- Date received
- 2005-06-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1) NEW STYLE 2000 MODERATE PLUS PROFILE, WHICH IS CONSIDERED A MODIFICATION TO THE EXISTING PRODUCT INE, WITH SIZES 175CC-800CC; 2) ADDITIONAL SIZES OF 400CC, 450CC, 500CC, 600CC, 650CC AND 800CC FOR STYLE 1600; AND 3) ADDITIONAL SIZES OF 350CC, 400CC, 700CC, 770CC, AND 800CC FOR STYLE 3000. THERE ARE NO CHANGES TO THE INDICATIONS FOR USE.