PMA P990074S043

Device: Natrelle Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S043
Product code: FWM
Decision date: 2019-12-04
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Changes in the sterilization validation of Natrelle Saline-Filled Breast Implants, including a change in the D-value of the biological indicators and a change in the sterilization validation approach.

Current openFDA PMA Record#

Device: Natrelle Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S043
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2019-12-04
Decision code: OK30
Date received: 2019-11-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes in the sterilization validation of Natrelle Saline-Filled Breast Implants, including a change in the D-value of the biological indicators and a change in the sterilization validation approach.