COFLEX INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/plate

FDA Premarket Approval P110008 S007

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 changes to the protocol for the post-approval study (pas) protocol.

DeviceCOFLEX INTERLAMINAR TECHNOLOGY
Classification NameProsthesis, Spinous Process Spacer/plate
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantPARADIGM SPINE, LLC
Date Received2016-10-18
Decision Date2017-03-10
PMAP110008
SupplementS007
Product CodeNQO
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address PARADIGM SPINE, LLC 505 Park Avenue, 14th Floor new York, NY 10022

Supplemental Filings

Supplement NumberDateSupplement Type
P110008Original Filing
S013 2021-01-06 Normal 180 Day Track No User Fee
S012 2020-07-09 Special (immediate Track)
S011 2019-10-29 Normal 180 Day Track No User Fee
S010 2017-08-17 Normal 180 Day Track No User Fee
S009 2017-07-03 Normal 180 Day Track No User Fee
S008 2017-06-26 Normal 180 Day Track
S007 2016-10-18 Normal 180 Day Track No User Fee
S006 2016-09-01 Real-time Process
S005 2016-03-09 Normal 180 Day Track No User Fee
S004 2016-01-14 30-day Notice
S003 2014-02-19 Normal 180 Day Track No User Fee
S002 2012-11-26 Normal 180 Day Track No User Fee
S001 2012-11-26 Normal 180 Day Track No User Fee

NIH GUDID Devices

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