CAPSURE SENSE MODEL 4074 AND 4574
FDA premarket approval P830061/S046 · decided 2009-04-28
Approval details
- PMA number
- P830061
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE SENSE MODEL 4074 AND 4574
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-03-17
- Decision date
- 2009-04-28
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES. THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.
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