MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD
FDA premarket approval P920015/S024 · decided 2001-11-02
Approval details
- PMA number
- P920015
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2001-10-01
- Decision date
- 2001-11-02
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD. THE DEVICE IS INDICATED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE. THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH ARRHYTHMIA MANAGEMENT SYSTEMS ARE INDICATED.
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