CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS + LEADS
FDA premarket approval P830061/S067 · decided 2011-07-07
Approval details
- PMA number
- P830061
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS + LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-06-08
- Decision date
- 2011-07-07
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
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