PMA P990074S047

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S047
Product code: FWM
Decision date: 2021-07-20
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Change to implement new temperature controllers used in the alcohol shell drying ovens in the manufacturing process of the Allergan Natrelle® Saline-Filled Breast Implants and the Allergan Natrelle® Silicone-Filled Breast Implants

Current openFDA PMA Record#

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S047
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2021-07-20
Decision code: OK30
Date received: 2021-06-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to implement new temperature controllers used in the alcohol shell drying ovens in the manufacturing process of the Allergan Natrelle® Saline-Filled Breast Implants and the Allergan Natrelle® Silicone-Filled Breast Implants