CAPSURE SENSE LEAD,VITATRON CRYSTALLINE LEAD
FDA premarket approval P830061/S101 · decided 2013-12-12
Approval details
- PMA number
- P830061
- Supplement
- S101
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE LEAD,VITATRON CRYSTALLINE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-11-27
- Decision date
- 2013-12-12
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF A SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY.
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