CardioGenesis TMR System

FDA Premarket Approval P970029 S040

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

DeviceCardioGenesis TMR System
Generic NameSystem, Laser, Transmyocardial Revascularization
ApplicantCRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP970029 Supplement NumberS040 Date Received08/04/2022 Decision Date09/01/2022 Product Code MNO  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-08-04
Decision Date2022-09-01
PMAP970029
SupplementS040
Product CodeMNO 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressCRYOLIFE, INC.
1655 Roberts Blvd., N.w.
kennesaw, GA 30144 PMA NumberP970029 Supplement NumberS040 Date Received08/04/2022 Decision Date09/01/2022 Product Code MNO  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Addition Of Chassis Grounding Resistance And Chassis Leakage Current Tests To The Service Manual For Use After Repair, Maintenance, And Installation Activities

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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