PMA P020056S059

Device
NATRELLE Silicone-Filled Breast Implants
Applicant
Allergan
PMA number
P020056
Supplement
S059
Product code
FTR
Decision date
2022-12-29
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
Approval for modifications to Physician and Patient Labeling.

Current openFDA PMA Record#

Device
NATRELLE Silicone-Filled Breast Implants
Applicant
Allergan
PMA number
P020056
Supplement
S059
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2022-12-29
Decision code
APPR
Date received
2022-04-04
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for modifications to Physician and Patient Labeling.