LEAD ADAPTOR/SPRINT QUATTRO/ SPRINT QUATTRO LEAD/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD
FDA premarket approval P920015/S084 · decided 2013-02-28
Approval details
- PMA number
- P920015
- Supplement
- S084
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LEAD ADAPTOR/SPRINT QUATTRO/ SPRINT QUATTRO LEAD/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2011-11-21
- Decision date
- 2013-02-28
- Days to decision
- 465 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE SPRINT QUATTRO DEFIBRILLATION LEAD ADAPTORS, SPRINT QUATTRO DEFIBRILLATION LEADS; TRANSVENE SVC DEFIBRILLATION LEAD, AND SUBCUTANEOUS DEFIBRILLATION LEAD.
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