PMA P990075S026
- Device
- SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S026
- Product code
- FWM
- Decision date
- 2014-08-12
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- CHANGE THE SUPPLIER OF AN ADDITIVE AND REPLACE THE ADDITIVE WITH ANOTHER VERSION OF THE SAME MATERIAL.
Current openFDA PMA Record#
- Device
- SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S026
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2014-08-12
- Decision code
- OK30
- Date received
- 2014-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE SUPPLIER OF AN ADDITIVE AND REPLACE THE ADDITIVE WITH ANOTHER VERSION OF THE SAME MATERIAL.