CAPSURE SP NOVUS LEAD MODEL 5594
FDA premarket approval P850089/S046 · decided 2001-06-14
Approval details
- PMA number
- P850089
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE SP NOVUS LEAD MODEL 5594
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-05-21
- Decision date
- 2001-06-14
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CAPSURE SP NOVUS LEAD MODEL 5594. THE DEVICE IS INDICATED FOR PACING AN DSENSING IN THE ATRIUM. THE LEAD HAS APPLICATIONS WHERE IMPLANTABLE ATRIAL SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED.
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