PMA P920015S274

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S274
Product code
NVY
Decision date
2023-01-16
Generic name
Permanent defibrillator electrodes
Approval order statement
Updates to the Final Packaging Process to allow manual loading.

Current openFDA PMA Record#

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S274
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2023-01-16
Decision code
OK30
Date received
2023-01-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to the Final Packaging Process to allow manual loading.