PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM

FDA premarket approval P160003 · Stent, Coronary

PMA numberP160003

Approval

Applicant
Biotronik AG
Received
January 19, 2016
Decision date
February 14, 2017 (APPR)
Supplements
25, latest June 5, 2026
Product code
MAF – Stent, Coronary

Official FDA PMA record

Approval order statement

Approval for the PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with de novo or restenotic lesions in native coronary arteries with a reference vessel diameter ranging from 2.25 mm to 4.0 mm and lesion length <= 31 mm.