PMA P990075S046
- Device
- Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S046
- Product code
- FWM
- Decision date
- 2019-11-19
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Qualification of new manufacturing equipment related to the removal of foreign debris from packaging used for Saline-Filled and Spectrum Breast Implants.
Current openFDA PMA Record#
- Device
- Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S046
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2019-11-19
- Decision code
- OK30
- Date received
- 2019-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of new manufacturing equipment related to the removal of foreign debris from packaging used for Saline-Filled and Spectrum Breast Implants.