TMR HOLMIUM LASER SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Premarket Approval P970029

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the eclipse tmr holmium laser system. Transmyocardial revascularization with the eclipse tmr system is indicated for treatment of stable patients with angina (canadian cardiovascular society class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium iwth reversible ischemia not amendable to direct coronary revascularization.

DeviceTMR HOLMIUM LASER SYSTEM
Classification NameSystem, Laser, Transmyocardial Revascularization
Generic NameSystem, Laser, Transmyocardial Revascularization
ApplicantCRYOLIFE, INC.
Date Received1997-07-02
Decision Date1999-02-11
Notice Date1999-07-19
PMAP970029
SupplementS
Product CodeMNO
Docket Number99M-2238
Advisory CommitteeCardiovascular
Expedited ReviewYes
Combination Product No
Applicant Address CRYOLIFE, INC. 1655 Roberts Blvd., N.w. kennesaw, GA 30144
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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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