PMA P950015S003

Device: HEART LASER CO2 TMR SYSTEM
Applicant: Laser Engineering Heart, Inc.
PMA number: P950015
Supplement: S003
Product code: MNO
Decision date: 1999-11-10
Classification: System, Laser, Transmyocardial Revascularization
Generic name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Approval order statement: Approval for a new study protocol, having both an accelerated aging and a real time aging arm, to demonstrate a two year shelf life for the TMR Disposable Kit (an accessory for The Heart Laser(TM) System). In addition, approval is requested to extend the shelf life for the TMR Disposable Kit from one year to two years, based on results of the accelerated aging portion of the proposed new protocol.

Current openFDA PMA Record#

Device: HEART LASER CO2 TMR SYSTEM
Applicant: Laser Engineering Heart, Inc.
PMA number: P950015
Supplement: S003
Product code: MNO
Generic name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Decision date: 1999-11-10
Decision code: APPR
Date received: 1999-05-14
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a new study protocol, having both an accelerated aging and a real time aging arm, to demonstrate a two year shelf life for the TMR Disposable Kit (an accessory for The Heart Laser(TM) System). In addition, approval is requested to extend the shelf life for the TMR Disposable Kit from one year to two years, based on results of the accelerated aging portion of the proposed new protocol.