Prestiege LP Cervical Disc - Two-Level

FDA Premarket Approval P090029 S013

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 for labeling for the prestige lp™ cervical disc which incorporated the final results of the 10-year extended follow-up of ide subjects post-approval study

DevicePrestiege LP Cervical Disc - Two-Level
Generic NameProsthesis, Intervertebral Disc
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2019-09-26
Decision Date2020-03-06
PMAP090029
SupplementS013
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132

Supplemental Filings

Supplement NumberDateSupplement Type
P090029Original Filing
S013 2019-09-26 Normal 180 Day Track No User Fee
S012 2019-05-23 Normal 180 Day Track No User Fee
S011 2018-10-31 Normal 180 Day Track No User Fee
S010 2018-09-18 Special (immediate Track)
S009 2017-12-11 Normal 180 Day Track No User Fee
S008 2017-07-13 Normal 180 Day Track No User Fee
S007 2016-12-22 Normal 180 Day Track
S006 2016-08-05 Normal 180 Day Track No User Fee
S005 2016-07-11 30-day Notice
S004 2015-09-02 Normal 180 Day Track No User Fee
S003 2015-06-03 Panel Track
S002 2014-08-22 Normal 180 Day Track No User Fee
S001 2014-08-08 Normal 180 Day Track No User Fee

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