PMA P990074S037

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S037
Product code: FWM
Decision date: 2017-08-28
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Approval for changes to the labeling including 1) the removal of the Betadine warning against breast implant exposure to Betadine brand povidone-iodine 10% (applicable to generic versions as well) from the patient and physician labeling, and 2) modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

Current openFDA PMA Record#

Device: NATRELLE Saline-Filled Breast Implants
Applicant: Allergan
PMA number: P990074
Supplement: S037
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2017-08-28
Decision code: APPR
Date received: 2017-03-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the labeling including 1) the removal of the Betadine warning against breast implant exposure to Betadine brand povidone-iodine 10% (applicable to generic versions as well) from the patient and physician labeling, and 2) modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).