Barricaid Annular Closure

FDA Premarket Approval P160050 S005

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 the revised protocol for the post-approval study (pas) referenced above

DeviceBarricaid Annular Closure
Generic NameReherniation Reduction Device
ApplicantINTRINSIC THERAPEUTICS
Date Received2020-04-16
Decision Date2020-05-12
PMAP160050
SupplementS005
Product CodeQES 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address INTRINSIC THERAPEUTICS 30 Commerce Way woburn, MA 01801

Supplemental Filings

Supplement NumberDateSupplement Type
P160050Original 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 IDPMASupp
M906BARA810MM0 P160050 000
M906BARA88MM0 P160050 000

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