PMA P920015S294

Device: DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S294
Product code: NVY
Decision date: 2024-11-13
Classification: Cardiovascular
Generic name: Permanent defibrillator electrodes
Approval order statement: to update the manufacturing execution system to FACTORYworks Release 10.0

Current openFDA PMA Record#

Device: DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S294
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2024-11-13
Decision code: OK30
Date received: 2024-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update the manufacturing execution system to FACTORYworks Release 10.0