MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
FDA premarket approval P950024/S002 · decided 1999-09-16
Approval details
- PMA number
- P950024
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 1998-07-01
- Decision date
- 1999-09-16
- Days to decision
- 442 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a new pacing lead model and is indicated for use with a pulse generator as part of a cardiac pacing system. The lead has application where implantable epicardial atrial or ventricular, single or dual chamber pacing systems are indicated.
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