CAPSURE SENSE LEAD
FDA premarket approval P830061/S086 · decided 2014-02-18
Approval details
- PMA number
- P830061
- Supplement
- S086
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE SENSE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-03-13
- Decision date
- 2014-02-18
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR REMOVAL OF THE DEXAMETHASONE SODIUM PHOSPHATE (DSP) COATING FROM THE LEAD TIP AND THE MANUFACTURING SITE CHANGE FOR THE MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) FOR THE CAPSURE SENSE FAMILY OF LEADS.
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