SPRINT QUATTRO, SPRINT QUATTRO SECURE MODELS 6947 AND 6935
FDA premarket approval P920015/S053 · decided 2009-04-28
Approval details
- PMA number
- P920015
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPRINT QUATTRO, SPRINT QUATTRO SECURE MODELS 6947 AND 6935
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2009-03-17
- Decision date
- 2009-04-28
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES. THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.
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