PMA P990075S007
- Device
- MENTOR SPECTRUM SALINE-FILLED MAMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S007
- Product code
- FWM
- Decision date
- 2002-04-23
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- CHANGE OF A SUPPLIER OF SILICONE GEL MATERIALS USED IN THE LUBRICATION OF THE SPECTRUM VALVE CHANNEL IN THE MENTOR SPECTRUM SALINE-FILLED BREAST IMPLANTS. THERE WILL BE NO CHANGES IN ANY MANUFACTURING PROCESSES.
Current openFDA PMA Record#
- Device
- MENTOR SPECTRUM SALINE-FILLED MAMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S007
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2002-04-23
- Decision code
- OK30
- Date received
- 2002-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF A SUPPLIER OF SILICONE GEL MATERIALS USED IN THE LUBRICATION OF THE SPECTRUM VALVE CHANNEL IN THE MENTOR SPECTRUM SALINE-FILLED BREAST IMPLANTS. THERE WILL BE NO CHANGES IN ANY MANUFACTURING PROCESSES.