PMA P040046S023
- Device
- NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S023
- Product code
- FTR
- Decision date
- 2017-07-05
- 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 for the shell assembly vulcanization process to collect and store temperature, pressure, and time data. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.
Current openFDA PMA Record#
- Device
- NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S023
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-07-05
- Decision code
- OK30
- Date received
- 2017-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an Electronic Data Acquisition (EDA) System for the shell assembly vulcanization process to collect and store temperature, pressure, and time data. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.