Barricaid Anular Closure

Reherniation Reduction Device

FDA Premarket Approval P160050 S001

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 of two protocols for the post-approval study (pas) protocol.

• Device: Barricaid Anular Closure
• Classification Name: Reherniation Reduction Device
• Generic Name: Reherniation Reduction Device
• Applicant: INTRINSIC THERAPEUTICS
• Date Received: 2019-03-08
• Decision Date: 2019-05-07
• PMA: P160050
• Supplement: S001
• Product Code: QES
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• 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