MEDTRONIC 350 SERIES PACING SYSTEM
FDA premarket approval P980035/S004 · decided 1999-12-09
Approval details
- PMA number
- P980035
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC 350 SERIES PACING SYSTEM
- Applicant
- Medtronic, Inc.
- Date received
- 1999-11-11
- Decision date
- 1999-12-09
- Days to decision
- 28 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Medtronic Model 350 Series Pacing System Programmed by the Medtronic Model 9790/C Programmer with Sigma Model 9963/9963A software.
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