PMA P030053S017

Device
MEMORYGEL BREAST IMPLANT
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S017
Product code
FTR
Decision date
2014-04-18
Classification
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
MEMORYGEL BREAST IMPLANT
Applicant
Mentor Corp.
PMA number
P030053
Supplement
S017
Product code
FTR
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date
2014-04-18
Decision code
APPR
Date received
2014-02-19
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.