PMA P020052S001

Device: CARDIOVERSION SWITCHBOX II SYSTEM
Applicant: St Jude Medical
PMA number: P020052
Supplement: S001
Product code: MTE
Decision date: 2003-08-22
Classification: Cardiovascular
Generic name: System, pacing, temporary, acute, internal atrial defibrillation
Approval order statement: APPROVAL FOR THE CARDIOVERSION SWITCHBOX II SYSTEM. THE DEVICE IS INDICATED AS FOLLOWS: THE CARDIOVERSION SWITCHBOX II SYSTEM CONNECTS A ST. JUDE MEDICAL CARDIOVERSION (CV) CATHETER AND EXTENSION CABLE TO A COMPATIBLE CARDIOVERTER/DEFIBRILLATOR AND EP RECORDING SYSTEM.

Current openFDA PMA Record#

Device: CARDIOVERSION SWITCHBOX II SYSTEM
Applicant: St Jude Medical
PMA number: P020052
Supplement: S001
Product code: MTE
Generic name: System, pacing, temporary, acute, internal atrial defibrillation
Decision date: 2003-08-22
Decision code: APPR
Date received: 2003-07-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CARDIOVERSION SWITCHBOX II SYSTEM. THE DEVICE IS INDICATED AS FOLLOWS: THE CARDIOVERSION SWITCHBOX II SYSTEM CONNECTS A ST. JUDE MEDICAL CARDIOVERSION (CV) CATHETER AND EXTENSION CABLE TO A COMPATIBLE CARDIOVERTER/DEFIBRILLATOR AND EP RECORDING SYSTEM.