PMA P960013

Device: Tendril STS; OptiSense; UltiPace
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S121
Product code: NVN
Decision date: 2026-02-19
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: an alternative sterilization site (Cycle 100 in Chamber 1 and 2, Abbott, Arecibo, PR) for analytical test articles (non-finished goods) comprising several cardiac leads and Aveir Leadless Pacemakers Monolithic Controlled Release Devices (MCRDs)

Current openFDA PMA Record#

Device: Tendril STS; OptiSense; UltiPace
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S129
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-02-19
Decision code: APPR
Date received: 2025-05-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative sterilization site (Cycle 100 in Chamber 1 and 2, Abbott, Arecibo, PR) for analytical test articles (non-finished goods) comprising several cardiac leads and Aveir Leadless Pacemakers Monolithic Controlled Release Devices (MCRDs)