PMA P020056

Device
NATRELLE Silicone-Filled Breast Implants
Applicant
Allergan
PMA number
P020056
Supplement
S059
Product code
FTR
Decision date
2024-12-16
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
changes to the adhesive coating that is used to secure the lids to the thermoformed trays

Current openFDA PMA Record#

Device
NATRELLE Silicone-Filled Breast Implants
Applicant
Allergan
PMA number
P020056
Supplement
S065
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2024-12-16
Decision code
OK30
Date received
2024-11-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
changes to the adhesive coating that is used to secure the lids to the thermoformed trays