PMA P020056S023

Device
NATRELLE SILICONE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P020056
Supplement
S023
Product code
FTR
Decision date
2015-08-03
Classification
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
APPROVAL FOR THE REDESIGN OF THE POST APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
NATRELLE SILICONE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P020056
Supplement
S023
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2015-08-03
Decision code
APPR
Date received
2013-10-08
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL FOR THE REDESIGN OF THE POST APPROVAL STUDY PROTOCOL.