PMA P920015S296

Device
Tunneling Tool
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S296
Product code
NVY
Decision date
2024-12-18
Classification
Cardiovascular
Generic name
Permanent defibrillator electrodes
Approval order statement
the update to the cleaning process for the rod and stopper for the 6996T tunneling tool

Current openFDA PMA Record#

Device
Tunneling Tool
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S296
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2024-12-18
Decision code
OK30
Date received
2024-12-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the update to the cleaning process for the rod and stopper for the 6996T tunneling tool