PMA P990069

Device: ALERT SYSTEM-COMPANION II
Applicant: Dot Medical Products , Ltd.
PMA number: P990069
Supplement: S001
Product code: MTE
Decision date: 2003-09-29
Classification: Cardiovascular
Generic name: System, pacing, temporary, acute, internal atrial defibrillation
Approval order statement: APPROVAL FOR THE ALERT SYSTEM, COMPANION II. THE DEVICE, AS MODIFIED, IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.

Current openFDA PMA Record#

Device: ALERT SYSTEM-COMPANION II
Applicant: Dot Medical Products , Ltd.
PMA number: P990069
Supplement: S001
Product code: MTE
Generic name: System, pacing, temporary, acute, internal atrial defibrillation
Decision date: 2003-09-29
Decision code: APPR
Date received: 2003-04-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ALERT SYSTEM, COMPANION II. THE DEVICE, AS MODIFIED, IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.