PMA P920015S305

Device
ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725), Sprint Qu
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S305
Product code
NVY
Decision date
2026-04-15
Classification
Cardiovascular
Generic name
Permanent defibrillator electrodes
Approval order statement
to reduce the bioburden monitoring frequency from bi-weekly to monthly

Current openFDA PMA Record#

Device
ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725), Sprint Qu
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S305
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2026-04-15
Decision code
OK30
Date received
2026-03-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to reduce the bioburden monitoring frequency from bi-weekly to monthly