PMA P990074S034

Device: NATRELLE SALINE FILLED BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S034
Product code: FWM
Decision date: 2016-10-20
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Change to the worst case device of the BIOCELL-textured, Natrelle Saline-Filled Breast Implant product line, for representative bioburden testing.

Current openFDA PMA Record#

Device: NATRELLE SALINE FILLED BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S034
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2016-10-20
Decision code: OK30
Date received: 2016-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the worst case device of the BIOCELL-textured, Natrelle Saline-Filled Breast Implant product line, for representative bioburden testing.