PMA P020056S058

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P020056
Supplement: S058
Product code: FTR
Decision date: 2022-10-05
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval for a change to the annual re-validation of the dry heat sterilization process to allow annual re-validation to be performed without biological indicators every other year.

Current openFDA PMA Record#

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P020056
Supplement: S058
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2022-10-05
Decision code: APPR
Date received: 2022-04-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change to the annual re-validation of the dry heat sterilization process to allow annual re-validation to be performed without biological indicators every other year.