VITATRON DIVA PACING SYSTEM
FDA premarket approval P990001/S003 · decided 2000-07-26
Approval details
- PMA number
- P990001
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON DIVA PACING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2000-05-16
- Decision date
- 2000-07-26
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE PARYLENE COATED VERSION OF THE SELECTION AFM 902 PULSE GENERATOR AND THE MODEL VSA02, VERSION 6.0 PROGRAMMER SOFTWARE.
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