PMA P160050S006

Device
Barricaid Annular Closure Device
Applicant
Intrinsic Therapeutics
PMA number
P160050
Supplement
S006
Product code
QES
Decision date
2020-05-19
Generic name
Reherniation reduction device
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
Barricaid Annular Closure Device
Applicant
Intrinsic Therapeutics
PMA number
P160050
Supplement
S006
Product code
QES
Generic name
Reherniation reduction device
Decision date
2020-05-19
Decision code
APPR
Date received
2020-04-22
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.