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).

DeviceBarricaid Anular Closure (ACD)
Generic NameReherniation Reduction Device
ApplicantINTRINSIC THERAPEUTICS
Date Received2019-03-19
Decision Date2020-03-17
PMAP160050
SupplementS003
Product CodeQES 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address INTRINSIC THERAPEUTICS 30 Commerce Way woburn, MA 01801

Supplemental Filings

Supplement NumberDateSupplement Type
P160050Original Filing
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 IDPMASupp
M906BARA810MM0 P160050 000
M906BARA88MM0 P160050 000

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