THE HEART LASER CO2 TMR SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Premarket Approval P950015 S002

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 changes to the labeling.

DeviceTHE HEART LASER CO2 TMR SYSTEM
Classification NameSystem, Laser, Transmyocardial Revascularization
Generic NameSystem, Laser, Transmyocardial Revascularization
ApplicantLaser Engineering Heart Inc.
Date Received1999-03-29
Decision Date1999-04-27
PMAP950015
SupplementS002
Product CodeMNO
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Laser Engineering Heart Inc. 475 Metroplex Drive, Suite 401 nashville, TN 37211

Supplemental Filings

Supplement NumberDateSupplement Type
P950015Original Filing
S012 2013-10-07 Normal 180 Day Track No User Fee
S011 2008-09-12 Normal 180 Day Track No User Fee
S010 2004-07-06 Normal 180 Day Track
S009
S008 2000-09-28 Normal 180 Day Track
S007 2000-09-12 Real-time Process
S006 1999-11-24 Special (immediate Track)
S005 1999-06-28 Normal 180 Day Track
S004
S003 1999-05-14 Normal 180 Day Track
S002 1999-03-29 Special (immediate Track)
S001 1998-09-21 Normal 180 Day Track

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