PMA P020056S043

Device
Natrelle Silicone-Filled Breast Implants
Applicant
Allergan
PMA number
P020056
Supplement
S043
Product code
FTR
Decision date
2017-08-01
Classification
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
Addition of two new Gruenberg gel curing ovens.

Current openFDA PMA Record#

Device
Natrelle Silicone-Filled Breast Implants
Applicant
Allergan
PMA number
P020056
Supplement
S043
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2017-08-01
Decision code
OK30
Date received
2017-07-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of two new Gruenberg gel curing ovens.