SPRINT QUATTRO LEADS
FDA premarket approval P920015/S099 · decided 2012-12-19
Approval details
- PMA number
- P920015
- Supplement
- S099
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPRINT QUATTRO LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2012-10-31
- Decision date
- 2012-12-19
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MECHANICAL DESIGN CHANGE TO THE SPRINT QUATTRO MODEL 6935M AND MODEL 6947M LEAD ANALYZER CABLE INTERFACE ACCESSORY.
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