BRYAN Cervical Disc

FDA Premarket Approval P060023 S008

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 bryan® cervical disc which incorporate the final results of the 10-year post-approval study and enhanced surveillance findings.

DeviceBRYAN Cervical Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2019-10-18
Decision Date2020-03-18
PMAP060023
SupplementS008
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
P060023Original Filing
S008 2019-10-18 Normal 180 Day Track No User Fee
S007
S006 2017-07-13 Normal 180 Day Track No User Fee
S005 2016-07-11 30-day Notice
S004 2012-12-13 30-day Notice
S003 2012-05-04 135 Review Track For 30-day Notice
S002 2011-04-15 135 Review Track For 30-day Notice
S001 2010-05-18 Normal 180 Day Track

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