PRO-DISC C TOTAL DISC REPLACEMENT

Prosthesis, Intervertebral Disc

FDA Premarket Approval P070001 S006

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

Change in the ha coating vendor.

DevicePRO-DISC C TOTAL DISC REPLACEMENT
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantCentinel Spine, LLC
Date Received2010-05-27
Decision Date2010-06-25
PMAP070001
SupplementS006
Product CodeMJO
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Centinel Spine, LLC 900 Airport Road, Suite 3b west Chester, PA 19380

Supplemental Filings

Supplement NumberDateSupplement Type
P070001Original Filing
S021 2021-09-21 30-day Notice
S020 2021-01-28 30-day Notice
S019
S018 2019-06-21 Normal 180 Day Track No User Fee
S017 2018-12-04 Normal 180 Day Track No User Fee
S016 2017-09-20 30-day Notice
S015 2017-06-30 30-day Notice
S014
S013 2014-04-03 135 Review Track For 30-day Notice
S012 2012-03-13 135 Review Track For 30-day Notice
S011 2011-07-19 30-day Notice
S010 2011-07-18 135 Review Track For 30-day Notice
S009 2010-08-02 Real-time Process
S008 2010-06-07 30-day Notice
S007 2010-06-02 30-day Notice
S006 2010-05-27 30-day Notice
S005 2010-05-27 135 Review Track For 30-day Notice
S004 2010-05-19 Normal 180 Day Track No User Fee
S003
S002 2008-03-12 Normal 180 Day Track No User Fee
S001 2008-01-31 Real-time Process

NIH GUDID Devices

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