MEDTRONIC SIGMA PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM
FDA premarket approval P980035/S029 · decided 2003-06-06
Approval details
- PMA number
- P980035
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SIGMA PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2003-05-12
- Decision date
- 2003-06-06
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE CONNECTOR IN THE SIGMA AND 350 SERIES PACEMAKERS TO IMPROVE YIELD AND MANUFACTURABILITY.
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