PMA P990075S037
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S037
- Product code
- FWM
- Decision date
- 2016-07-05
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S037
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2016-07-05
- Decision code
- OK30
- Date received
- 2016-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.