PRESTIGE LP Cervical Disc

FDA Premarket Approval P090029 S015

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 replace the current deionized water system to a new reverse osmosis & deionized water system with new piping and fixtures. This change applies to the water system is being replaced by a new reverse osmosis & deionized water system with new piping and fixtures. The following manufacturing facility is affected by the change(s): orchid orthopedics solutions, 23149 commerce drive, farmington hills, mi 48335 usa.

DevicePRESTIGE LP Cervical Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2020-10-21
Decision Date2020-12-01
PMAP090029
SupplementS015
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S015 2020-10-21 30-day Notice
S014 2020-03-18 30-day Notice
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

NIH GUDID Devices

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