PMA P990074S028

Device: NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S028
Product code: FWM
Decision date: 2014-03-27
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: APPROVAL FOR A CHANGE TO THE MATERIAL USED FOR THE FILL TUBE TIP ANDLUER ADAPTER OF THE FILL TUBE ASSEMBLY FOR NATRELLE SALINE-FILLED BREAST IMPLANTS FROM PRO-FAX PD626 POLYPROPYLENE HOMOPOLYMER TO P5M6K-080 POLYPROPYLENE COPOLYMER.

Current openFDA PMA Record#

Device: NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S028
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2014-03-27
Decision code: APPR
Date received: 2013-12-31
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE MATERIAL USED FOR THE FILL TUBE TIP ANDLUER ADAPTER OF THE FILL TUBE ASSEMBLY FOR NATRELLE SALINE-FILLED BREAST IMPLANTS FROM PRO-FAX PD626 POLYPROPYLENE HOMOPOLYMER TO P5M6K-080 POLYPROPYLENE COPOLYMER.