Sprint Quattro Lead
FDA premarket approval P920015/S256 · decided 2021-09-15
Approval details
- PMA number
- P920015
- Supplement
- S256
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Sprint Quattro Lead
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2021-06-16
- Decision date
- 2021-09-15
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the removal of steroid coating from the lead helix electrode and to provide chemistry, manufacturing and controls information.
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