PMA P920015S293

Device: DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead. Subcutaneous Lead, Transvene C
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S293
Product code: NVY
Decision date: 2024-10-17
Classification: Cardiovascular
Generic name: Permanent defibrillator electrodes
Approval order statement: to update a silicone raw material incoming inspection procedure, location, and frequency

Current openFDA PMA Record#

Device: DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead. Subcutaneous Lead, Transvene C
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S293
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2024-10-17
Decision code: OK30
Date received: 2024-10-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update a silicone raw material incoming inspection procedure, location, and frequency