PMA P990074S048

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S048
Product code: FWM
Decision date: 2021-07-30
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Installation of a new patch curing oven and electronic data acquisition system for the manufacture of silicone-filled and saline-filled breast implants at Allergans Costa Rica facility.

Current openFDA PMA Record#

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S048
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2021-07-30
Decision code: OK30
Date received: 2021-06-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Installation of a new patch curing oven and electronic data acquisition system for the manufacture of silicone-filled and saline-filled breast implants at Allergans Costa Rica facility.