PMA P850089S163

Device: CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P850089
Supplement: S163
Product code: NVN
Decision date: 2022-11-22
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker 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: CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P850089
Supplement: S163
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker 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.