SPRINT QUATTRO MODEL 6944 LEAD
FDA premarket approval P920015/S017 · decided 2000-12-15
Approval details
- PMA number
- P920015
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPRINT QUATTRO MODEL 6944 LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2000-06-20
- Decision date
- 2000-12-15
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC(R) SPRINT(TM) QUATTRO(TM) MODEL 6944 LEAD WHICH IS INTENDED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE. THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS ARE INDICATED.
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