SPRINT QUATTRO LEADS MODELS 6935/6947
FDA premarket approval P920015/S069 · decided 2010-11-10
Approval details
- PMA number
- P920015
- Supplement
- S069
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPRINT QUATTRO LEADS MODELS 6935/6947
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2010-10-22
- Decision date
- 2010-11-10
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR LABELING CHANGES WARNING PHYSICIANS ABOUT OVER-RETRACTION OF THE HELIX IN THE SUBJECT LEADS.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |