PMA P020056S026

Device
NATRELLE SILICONE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P020056
Supplement
S026
Product code
FTR
Decision date
2015-02-25
Classification
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
APPROVAL FOR A LINE EXTENSION IDENTIFIED AS THE NATRELLE INSPIRA SILICONE-FILLED BREAST IMPLANTS TO ADD BREAST IMPLANT OPTIONS TO THE NATRELLE SILICONE-FILLED BREAST IMPLANTS.

Current openFDA PMA Record#

Device
NATRELLE SILICONE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P020056
Supplement
S026
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2015-02-25
Decision code
APPR
Date received
2014-08-29
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A LINE EXTENSION IDENTIFIED AS THE NATRELLE INSPIRA SILICONE-FILLED BREAST IMPLANTS TO ADD BREAST IMPLANT OPTIONS TO THE NATRELLE SILICONE-FILLED BREAST IMPLANTS.