PMA P990075S041
- Device
- Mentor Saline-Filled and SPECTRUM® Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S041
- Product code
- FWM
- Decision date
- 2017-05-24
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Conversion from the use of Biological Indicators to the use of Parametric Release for batch release of dry heat sterilized devices at the Mentor Texas facility.
Current openFDA PMA Record#
- Device
- Mentor Saline-Filled and SPECTRUM® Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S041
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2017-05-24
- Decision code
- OK30
- Date received
- 2017-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Conversion from the use of Biological Indicators to the use of Parametric Release for batch release of dry heat sterilized devices at the Mentor Texas facility.