PRESTIGE LP CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Premarket Approval P090029 S004

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

For a manufacturing site located at orchid detroit, 23149 commerce drive, farmington hills, mi 48335.

DevicePRESTIGE LP CERVICAL DISC
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2015-09-02
Decision Date2016-06-07
PMAP090029
SupplementS004
Product CodeMJO
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation 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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