PMA P990075S039
- Device
- Mentor Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S039
- Product code
- FWM
- Decision date
- 2017-04-10
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Addition of a new semi-automated secondary packaging line which will include electronic label and component verification equipment.
Current openFDA PMA Record#
- Device
- Mentor Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S039
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2017-04-10
- Decision code
- OK30
- Date received
- 2017-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new semi-automated secondary packaging line which will include electronic label and component verification equipment.