PMA P990074S023

Device: NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S023
Product code: FWM
Decision date: 2013-09-10
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: APPROVAL FOR PHYSICIAN AND PATIENT LABELING REVISIONS TO INCLUDE INFORMATION ABOUT ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) AND CONNECTIVE TISSUE DISEASE (CTD) RISKS WITH THE NATRELLE® SALINE-FILLED BREAST IMPLANT.

Current openFDA PMA Record#

Device: NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant: Allergan
PMA number: P990074
Supplement: S023
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2013-09-10
Decision code: APPR
Date received: 2011-01-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR PHYSICIAN AND PATIENT LABELING REVISIONS TO INCLUDE INFORMATION ABOUT ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) AND CONNECTIVE TISSUE DISEASE (CTD) RISKS WITH THE NATRELLE® SALINE-FILLED BREAST IMPLANT.