
Johnson & Johnson Interventional Systems
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PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION is an FDA 510(k)-cleared medical device (K911581) manufactured by Johnson & Johnson Interventional Systems. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 1991. Regulation: 8.