PMA P040046S026
- Device
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S026
- Product code
- FTR
- Decision date
- 2017-11-03
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Implement an Electronic Data Acquisition (EDA) System to collect cycle parameter, such as temperature and time, for the shell drying after washing and gel curing after shell filling occur in the Blue-M oven. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.
Current openFDA PMA Record#
- Device
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S026
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-11-03
- Decision code
- OK30
- Date received
- 2017-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an Electronic Data Acquisition (EDA) System to collect cycle parameter, such as temperature and time, for the shell drying after washing and gel curing after shell filling occur in the Blue-M oven. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.