PMA P990074S036

Device
NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P990074
Supplement
S036
Product code
FWM
Decision date
2017-02-17
Classification
Prosthesis, Breast, Inflatable, Internal, Saline
Generic name
Prosthesis, breast, inflatable, internal, saline
Approval order statement
Approval for minor design modifications to previously approved packaging configurations and the use of this packaging with additional devices.

Current openFDA PMA Record#

Device
NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P990074
Supplement
S036
Product code
FWM
Generic name
Prosthesis, breast, inflatable, internal, saline
Decision date
2017-02-17
Decision code
APPR
Date received
2016-11-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor design modifications to previously approved packaging configurations and the use of this packaging with additional devices.