Ascension MCP

Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis

FDA Premarket Approval P000057 S011

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 changes to the package insert, surgical technique, patient information brochure, and post-operative therapy brochure

DeviceAscension MCP
Classification NameFinger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis
Generic NameFinger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis
ApplicantINTEGRA LIFESCIENCES CORPORATION
Date Received2018-10-10
Decision Date2019-03-05
PMAP000057
SupplementS011
Product CodeNEG
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address INTEGRA LIFESCIENCES CORPORATION 8900 Cameron Road austin, TX 78754

Supplemental Filings

Supplement NumberDateSupplement Type
P000057Original Filing
S011 2018-10-10 Normal 180 Day Track No User Fee
S010 2017-10-03 Normal 180 Day Track No User Fee
S009 2016-06-21 Real-time Process
S008 2014-10-01 Normal 180 Day Track No User Fee
S007 2013-09-10 Real-time Process
S006 2010-04-07 135 Review Track For 30-day Notice
S005 2009-10-05 Normal 180 Day Track No User Fee
S004 2008-02-19 Real-time Process
S003 2006-02-06 Normal 180 Day Track
S002 2003-07-02 Real-time Process
S001 2001-12-19 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
M269MCP10050PWW1 P000057 007
00885556856802 P000057 007
00885556856789 P000057 007
00885556856765 P000057 007
00885556856741 P000057 007
00885556856727 P000057 007
00885556856819 P000057 007
00885556856796 P000057 007
00885556856772 P000057 007
00885556856758 P000057 007
00885556856734 P000057 007
00885556856826 P000057 007
M269MCP11005DWW1 P000057 007
M269MCP10050DWW1 P000057 007
M269MCP10040PWW1 P000057 007
M269MCP10040DWW1 P000057 007
M269MCP10030PWW1 P000057 007
M269MCP10030DWW1 P000057 007
M269MCP10020PWW1 P000057 007
M269MCP10020DWW1 P000057 007
M269MCP10010PWW1 P000057 007
M269MCP10010DWW1 P000057 007
M269MCP11005PWW1 P000057 007
00885556856710 P000057 007

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