PMA P160050S011

Device
Barricaid® Annular Closure Device
Applicant
Intrinsic Therapeutics
PMA number
P160050
Supplement
S011
Product code
QES
Decision date
2025-12-18
Classification
Orthopedic
Generic name
Reherniation reduction device
Approval order statement
approval for manufacturing process changes to the delivery instrument of the Barricaid Annular Closure Device

Current openFDA PMA Record#

Device
Barricaid® Annular Closure Device
Applicant
Intrinsic Therapeutics
PMA number
P160050
Supplement
S011
Product code
QES
Generic name
Reherniation reduction device
Decision date
2025-12-18
Decision code
OK30
Date received
2025-11-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for manufacturing process changes to the delivery instrument of the Barricaid Annular Closure Device