PMA P830061S206

Device: Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S206
Product code: NVN
Decision date: 2022-04-21
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: Updates to the equipment used for monitoring temperature and humidity in Controlled Environment Area number 2 at Medtronic Rice Creek.

Current openFDA PMA Record#

Device: Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S206
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2022-04-21
Decision code: OK30
Date received: 2022-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Updates to the equipment used for monitoring temperature and humidity in Controlled Environment Area number 2 at Medtronic Rice Creek.