PMA P990074S029

Device
NATRELLE SALINE FILLED BREST IMPLANTS
Applicant
Allergan
PMA number
P990074
Supplement
S029
Product code
FWM
Decision date
2015-02-11
Classification
Prosthesis, Breast, Inflatable, Internal, Saline
Generic name
Prosthesis, breast, inflatable, internal, saline
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRO-TECH DESIGN AND MANUFACTURING, INC., IN ARLINGTON, TEXAS.

Current openFDA PMA Record#

Device
NATRELLE SALINE FILLED BREST IMPLANTS
Applicant
Allergan
PMA number
P990074
Supplement
S029
Product code
FWM
Generic name
Prosthesis, breast, inflatable, internal, saline
Decision date
2015-02-11
Decision code
APPR
Date received
2014-05-30
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRO-TECH DESIGN AND MANUFACTURING, INC., IN ARLINGTON, TEXAS.