PMA P920015S254

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S254
Product code
NVY
Decision date
2021-03-29
Generic name
Permanent defibrillator electrodes
Approval order statement
Relocate the final packaging operations and select processing and equipment.

Current openFDA PMA Record#

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S254
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2021-03-29
Decision code
OK30
Date received
2021-03-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Relocate the final packaging operations and select processing and equipment.