CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+LEAD
FDA premarket approval P830061/S105 · decided 2014-01-16
Approval details
- PMA number
- P830061
- Supplement
- S105
- 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 PS+LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-12-24
- Decision date
- 2014-01-16
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
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