Barricaid Anular Closure (ACD)

FDA Premarket Approval P160050 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to change the supplier and specifications of the polyester yarn used to make the mesh of the woven fabric for the flexible occlusion component of the barricaid anular closure device (acd).

• Device: Barricaid Anular Closure (ACD)
• Generic Name: Reherniation Reduction Device
• Applicant: INTRINSIC THERAPEUTICS
• Date Received: 2019-03-19
• Decision Date: 2020-03-17
• PMA: P160050
• Supplement: S003
• Product Code: QES
• Advisory Committee: Orthopedic
• Supplement Type: Real-time Process
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: INTRINSIC THERAPEUTICS 30 Commerce Way woburn, MA 01801

Supplemental Filings

Supplement Number	Date	Supplement Type
P160050		Original Filing
S006	2020-04-22	Normal 180 Day Track No User Fee
S005	2020-04-16	Normal 180 Day Track No User Fee
S004
S003	2019-03-19	Real-time Process
S002	2019-03-11	135 Review Track For 30-day Notice
S001	2019-03-08	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
M906BARA810MM0	P160050	000
M906BARA88MM0	P160050	000