VITATRON(R) DEMA PACING SYSTEM
FDA premarket approval P990001/S004 · decided 2000-11-13
Approval details
- PMA number
- P990001
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON(R) DEMA PACING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2000-05-17
- Decision date
- 2000-11-13
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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.
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