THE HEART LASER CO2 TMR SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Premarket Approval P950015 S001

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 the post approval clinical study to be conducted as a condition of approval.

DeviceTHE HEART LASER CO2 TMR SYSTEM
Classification NameSystem, Laser, Transmyocardial Revascularization
Generic NameSystem, Laser, Transmyocardial Revascularization
ApplicantLaser Engineering Heart Inc.
Date Received1998-09-21
Decision Date1998-10-06
PMAP950015
SupplementS001
Product CodeMNO
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonPostapproval Study Protocol - Ode/oir
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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