PMA P990001S004

Device: VITATRON(R) DEMA PACING SYSTEM
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S004
Product code: DXY
Decision date: 2000-11-13
Generic name: implantable pacemaker Pulse-generator
Approval order statement: APPROVAL FOR THE DEMA PACING SYSTEM AND THE CITATRON APPLICATION SOFTWARE MODEL VSA02, VERSION 6. THE DEMA PACING SYSTEM CONSISTS OF THE FOLLOWING PULSE GENERATORS: CLARITY DDR MODELS 860, 862, 865; CLARITY SSIR MODELS 560, 562, 565; DIAMOND 3 MODEL 840; RUBY 3 MODEL 740; TOPAZ 3 MODEL 540; JADE 3 MODEL 340; VITA 2 DDR MODEL 830; VITA 2 MODEL 530.

Current openFDA PMA Record

Device: VITATRON(R) DEMA PACING SYSTEM
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S004
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2000-11-13
Decision code: APPR
Date received: 2000-05-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE DEMA PACING SYSTEM AND THE CITATRON APPLICATION SOFTWARE MODEL VSA02, VERSION 6. THE DEMA PACING SYSTEM CONSISTS OF THE FOLLOWING PULSE GENERATORS: CLARITY DDR MODELS 860, 862, 865; CLARITY SSIR MODELS 560, 562, 565; DIAMOND 3 MODEL 840; RUBY 3 MODEL 740; TOPAZ 3 MODEL 540; JADE 3 MODEL 340; VITA 2 DDR MODEL 830; VITA 2 MODEL 530.