NU VASIVE PCM CERVICAL DISC SYSTEM

Prosthesis, Intervertebral Disc

FDA Premarket Approval P100012 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

Approval for a locking plate design modification, additional device sizes and magnetic resonance (mr) conditional labeling.

DeviceNU VASIVE PCM CERVICAL DISC SYSTEM
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantNUVASIVE, INC.
Date Received2014-09-26
Decision Date2014-12-19
PMAP100012
SupplementS006
Product CodeMJO
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address NUVASIVE, INC. 7475 Lusk Blvd san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P100012Original Filing
S008 2018-05-03 Normal 180 Day Track No User Fee
S007
S006 2014-09-26 Normal 180 Day Track
S005 2013-12-18 Real-time Process
S004 2013-03-04 Normal 180 Day Track No User Fee
S003 2012-11-19 Normal 180 Day Track No User Fee
S002 2013-01-22 Special (immediate Track)
S001 2012-11-19 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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