PMA P990074S030

Device
NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P990074
Supplement
S030
Product code
FWM
Decision date
2014-11-04
Classification
Prosthesis, Breast, Inflatable, Internal, Saline
Generic name
Prosthesis, breast, inflatable, internal, saline
Approval order statement
APPROVAL FOR AN ALTERNATE MATERIAL FOR ONE COMPONENT USED IN THE FILL TUBE FOR NATRELLE SALINE-FILLED BREAST IMPLANTS.

Current openFDA PMA Record#

Device
NATRELLE SALINE-FILLED BREAST IMPLANTS
Applicant
Allergan
PMA number
P990074
Supplement
S030
Product code
FWM
Generic name
Prosthesis, breast, inflatable, internal, saline
Decision date
2014-11-04
Decision code
APPR
Date received
2014-08-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR AN ALTERNATE MATERIAL FOR ONE COMPONENT USED IN THE FILL TUBE FOR NATRELLE SALINE-FILLED BREAST IMPLANTS.