Cartiva Synthetic Cartilage Implant

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Premarket Approval P150017 S014

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

Expansion of the release criteria of final, finished devices to accept those that have a homogenously opaque appearance

DeviceCartiva Synthetic Cartilage Implant
Classification NameProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
Generic NameProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
ApplicantCartiva, Inc
Date Received2019-10-30
Decision Date2019-11-26
PMAP150017
SupplementS014
Product CodePNW
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cartiva, Inc 6120 Windward Parkway suite 220 alpharetta, GA 30005

Supplemental Filings

Supplement NumberDateSupplement Type
P150017Original Filing
S014 2019-10-30 30-day Notice
S013
S012 2019-02-22 Special (immediate Track)
S011
S010
S009 2018-06-06 30-day Notice
S008 2018-06-04 30-day Notice
S007 2017-11-15 Normal 180 Day Track No User Fee
S006 2017-10-13 30-day Notice
S005 2017-01-31 Special (immediate Track)
S004 2016-12-06 30-day Notice
S003 2016-08-15 Real-time Process
S002 2016-08-01 Normal 180 Day Track No User Fee
S001 2016-08-01 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00852897002151 P150017 000
00852897002038 P150017 000
00852897002045 P150017 000
00852897002052 P150017 000
00852897002069 P150017 000
00852897002076 P150017 000
00852897002083 P150017 000
00852897002090 P150017 000
00852897002106 P150017 000
00852897002113 P150017 000
00852897002120 P150017 000
00852897002137 P150017 000
00852897002144 P150017 000
00852897002021 P150017 000

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