CardioGenesis TMR System

System, Laser, Transmyocardial Revascularization

FDA Premarket Approval P970029 S033

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 change in material used in the construction of the handpieces.

DeviceCardioGenesis TMR System
Classification NameSystem, Laser, Transmyocardial Revascularization
Generic NameSystem, Laser, Transmyocardial Revascularization
ApplicantCRYOLIFE, INC.
Date Received2017-05-10
Decision Date2017-08-07
PMAP970029
SupplementS033
Product CodeMNO
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CRYOLIFE, INC. 1655 Roberts Blvd., N.w. kennesaw, GA 30144

Supplemental Filings

Supplement NumberDateSupplement Type
P970029Original Filing
S040 2022-08-04 Special (immediate Track)
S039 2019-04-18 30-day Notice
S038
S037 2018-06-12 30-day Notice
S036 2017-08-14 30-day Notice
S035 2017-06-29 30-day Notice
S034 2017-06-09 Real-time Process
S033 2017-05-10 Normal 180 Day Track
S032 2016-08-12 Special (immediate Track)
S031
S030 2016-05-25 30-day Notice
S029 2016-05-25 30-day Notice
S028 2015-12-11 Special (immediate Track)
S027 2015-02-13 Normal 180 Day Track No User Fee
S026 2014-04-09 Special (immediate Track)
S025 2013-11-26 Normal 180 Day Track No User Fee
S024 2013-01-29 Real-time Process
S023
S022 2012-10-19 Normal 180 Day Track No User Fee
S021 2012-08-16 Special (immediate Track)
S020 2012-06-27 Special (immediate Track)
S019 2012-03-27 Normal 180 Day Track No User Fee
S018 2011-11-17 30-day Notice
S017 2010-03-19 Special (immediate Track)
S016
S015 2009-08-31 Normal 180 Day Track No User Fee
S014 2009-07-30 Normal 180 Day Track
S013 2008-10-22 Normal 180 Day Track No User Fee
S012 2008-08-15 Special (immediate Track)
S011 2007-05-09 Normal 180 Day Track
S010
S009 2004-03-24 Normal 180 Day Track
S008 2001-10-05 Normal 180 Day Track
S007 2001-05-25 Special (immediate Track)
S006 2001-01-24 Normal 180 Day Track
S005 2000-11-09 Special (immediate Track)
S004
S003 1999-12-06 Special (immediate Track)
S002
S001 1999-03-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00877234000102 P970029 001
00877234000096 P970029 009
00877234000119 P970029 011

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