PMA P920015S273

Device: HV Splitter/Adaptor Kit, Sprint Quattro Lead
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S273
Product code: NVY
Decision date: 2022-11-22
Generic name: Permanent defibrillator electrodes
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.

Current openFDA PMA Record#

Device: HV Splitter/Adaptor Kit, Sprint Quattro Lead
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S273
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.