CAPSURE EPICARDIAL PACING LEAD
FDA premarket approval P950024/S050 · decided 2013-07-23
Approval details
- PMA number
- P950024
- Supplement
- S050
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE EPICARDIAL PACING LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2013-05-17
- Decision date
- 2013-07-23
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
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