PMA P950015S006

Device
HEART LASER(TM) CO2 TMR SYSTEM
Applicant
Laser Engineering Heart, Inc.
PMA number
P950015
Supplement
S006
Product code
MNO
Decision date
2000-01-11
Classification
System, Laser, Transmyocardial Revascularization
Generic name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Approval order statement
SUPPLEMENTARY PRODUCT LABELING

Current openFDA PMA Record#

Device
HEART LASER(TM) CO2 TMR SYSTEM
Applicant
Laser Engineering Heart, Inc.
PMA number
P950015
Supplement
S006
Product code
MNO
Generic name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Decision date
2000-01-11
Decision code
APPR
Date received
1999-11-24
Supplement type
Special (Immediate Track)
Approval order statement
SUPPLEMENTARY PRODUCT LABELING