PRESTIGE CERVICAL DISC

FDA Premarket Approval P060018 S003

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

Change the sterilization testing procedure.

• Device: PRESTIGE CERVICAL DISC
• Generic Name: Prosthesis, Intervertebral Disc
• Applicant: MEDTRONIC SOFAMOR DANEK, INC.
• Date Received: 2013-06-14
• Decision Date: 2013-07-12
• PMA: P060018
• Supplement: S003
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place memphis, TN 38132

Supplemental Filings

Supplement Number	Date	Supplement Type
P060018		Original Filing
S005	2016-07-11	30-day Notice
S004	2016-01-29	Normal 180 Day Track No User Fee
S003	2013-06-14	30-day Notice
S002	2010-10-26	135 Review Track For 30-day Notice
S001	2007-09-07	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
00721902440236	P060018	000
00721902440243	P060018	000
00721902440250	P060018	000
00721902451959	P060018	000
00721902723223	P060018	000
00721902723254	P060018	000
00613994129215	P060018	000
00613994129222	P060018	000
00613994129239	P060018	000
00613994129253	P060018	000
00613994236982	P060018	001
00613994237002	P060018	001
00613994237019	P060018	001
00613994237033	P060018	001
00613994237040	P060018	001
00613994237064	P060018	001