PMA P990075S067
- Device
- MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S067
- Product code
- FWM
- Decision date
- 2026-02-04
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- To seek approval of updating quarterly quality control EndoSafe Endotoxin Test Method
Current openFDA PMA Record#
- Device
- MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S067
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2026-02-04
- Decision code
- OK30
- Date received
- 2026-01-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- To seek approval of updating quarterly quality control EndoSafe Endotoxin Test Method