PMA P990075S036
- Device
- MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S036
- Product code
- FWM
- Decision date
- 2016-04-15
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.
Current openFDA PMA Record#
- Device
- MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S036
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2016-04-15
- Decision code
- OK30
- Date received
- 2016-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.