PMA P980016S003

Device: MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S003
Decision date: 1999-07-27
Approval order statement: Approval for the Model 7229 (GEM(TM) II VR) Implantable Cardioverter Defibrillator and Model 9964 Application Software and the quality assurance test method and specification for screening the GEM(TM) II VR for premature battery depletion, and the revised L222 integrated circuit.

Current openFDA PMA Record#

Device: MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S003
Decision date: 1999-07-27
Decision code: APPR
Date received: 1999-02-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Model 7229 (GEM(TM) II VR) Implantable Cardioverter Defibrillator and Model 9964 Application Software and the quality assurance test method and specification for screening the GEM(TM) II VR for premature battery depletion, and the revised L222 integrated circuit.