Medtronic Wiktor Prime Coronary Stent Delivery System

FDA premarket approval P960010 · Stent, Coronary

PMA numberP960010

Approval

Applicant
Medtronics Interventional Vascular
Received
May 1, 1996
Decision date
June 27, 1997 (APWD)
Supplements
1, latest May 21, 1998
Product code
MAF – Stent, Coronary

Official FDA PMA record

Approval order statement

APPROVAL FOR THE MEDTRONIC WIKTOR(R) PRIME CORONARY STENT DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN NATIVE CORONARY ARTERIES AND BYPASS GRAFT VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 3.0 TO 4.5 MM.