CAPSURE EPI PACING LEADS
FDA premarket approval P950024/S044 · decided 2012-11-27
Approval details
- PMA number
- P950024
- Supplement
- S044
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- CAPSURE EPI PACING LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2012-09-14
- Decision date
- 2012-11-27
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO ADD MODEL 4968 POST-APPROVAL STUDY RESULTS TO THE DEVICE LABELING.
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