PMA P990074S038

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S038
Product code: FWM
Decision date: 2017-10-13
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Approval of a planned manufacturing capacity expansion at the Costa Rica manufacturing facility and the addition of manufacturing equipment.

Current openFDA PMA Record#

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S038
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2017-10-13
Decision code: APPR
Date received: 2017-04-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of a planned manufacturing capacity expansion at the Costa Rica manufacturing facility and the addition of manufacturing equipment.