SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935
FDA premarket approval P920015/S039 · decided 2008-04-29
Approval details
- PMA number
- P920015
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2008-03-03
- Decision date
- 2008-04-29
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A SINGLE-DEFIBRILLATION-COIL VERSION OF THE FDA APPROVED SPRINT QUATTRO MODEL 6947 DUAL-DEFIBRILLATION ?COIL ACTIVE-FIXATION RIGHT VENTRICULAR LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER TE TRADE NAME SPRINT QUATTRO MODEL 6935 LEAD AND IS INTENDED FOR LONG-TERM USE IN THE RIGHT VENTRICLE FOR PATIENTS INDICATED FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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