AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

FDA Premarket Approval P000028 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

DeviceAFFINITY ANTERIOR CERVICAL CAGE SYSTEM
Generic NameIntervertebral Fusion Device With Bone Graft, Lumbar
ApplicantMedtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000028 Supplement NumberS008 Date Received04/20/2006 Decision Date07/25/2006 Reclassified Date 07/12/2007 Product Code MAX  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2006-04-20
Decision Date2006-07-25
PMAP000028
SupplementS008
Product CodeMAX 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
memphis, TN 38132 PMA NumberP000028 Supplement NumberS008 Date Received04/20/2006 Decision Date07/25/2006 Reclassified Date 07/12/2007 Product Code MAX  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
APPROVAL FOR CHANGES TO THE DEVICE LABELING TO INCORPORATE DATA COLLECTED FROM THE POST MARKET STUDY OF THE DEVICE.

Supplemental Filings

Supplement NumberDateSupplement Type
P000028Original Filing
S008 2006-04-20 Normal 180 Day Track No User Fee
S007
S006 2004-07-30 30-day Notice
S005 2004-05-19 Special (immediate Track)
S004 2003-08-27 Normal 180 Day Track No User Fee
S003 2002-11-08 Normal 180 Day Track
S002 2002-07-15 Normal 180 Day Track
S001 2002-07-09 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00721902307867 P000028 000
00721902307676 P000028 000
00721902307690 P000028 000
00721902307706 P000028 000
00721902307713 P000028 000
00721902307737 P000028 000
00721902307775 P000028 000
00721902307782 P000028 000
00721902307805 P000028 000
00721902307829 P000028 000
00721902307836 P000028 000
00721902307843 P000028 000
00721902307850 P000028 000
00721902307652 P000028 000

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