CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD; VITATRON EXCELLENCE LEAD PS+LEAD
FDA premarket approval P830061/S125 · decided 2016-01-13
Approval details
- PMA number
- P830061
- Supplement
- S125
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD; VITATRON EXCELLENCE LEAD PS+LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-12-22
- Decision date
- 2016-01-13
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
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