PMA P920015S256
- Device
- Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- Product code
- NVY
- Decision date
- 2021-09-15
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- Approval for the removal of steroid coating from the lead helix electrode and to provide chemistry, manufacturing and controls information.
Current openFDA PMA Record#
- Device
- Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S256
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2021-09-15
- Decision code
- APPR
- Date received
- 2021-06-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the removal of steroid coating from the lead helix electrode and to provide chemistry, manufacturing and controls information.