PMA P990075S008
- Device
- MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S008
- Product code
- FWM
- Decision date
- 2002-06-07
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- CHANGE OF SUPPLIER FOR MOLDED SILICONE COMPONENTS TO PORGES, DIVISION OF MENTOR, SARLAT SEDEX, FRANCE AND A CHANGE IN SUPPLIER OF THE RAW MATERIAL FROM DOW CORNING TO NUSIL FOR ONE MOLDED COMPONENT.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S008
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2002-06-07
- Decision code
- OK30
- Date received
- 2002-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF SUPPLIER FOR MOLDED SILICONE COMPONENTS TO PORGES, DIVISION OF MENTOR, SARLAT SEDEX, FRANCE AND A CHANGE IN SUPPLIER OF THE RAW MATERIAL FROM DOW CORNING TO NUSIL FOR ONE MOLDED COMPONENT.