PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION

Stents, Drains And Dilators For The Biliary Ducts

JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS

The following data is part of a premarket notification filed by Johnson & Johnson Interventional Systems with the FDA for Palmaz(tm) Balloon-expandable Stent, Modification.

Pre-market Notification Details

Device IDK911581
510k NumberK911581
Device Name:PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 150 MT. BETHEL RD. P.O. BOX 4917 Warren,  NJ  07059
ContactJames P O'donnell
CorrespondentJames P O'donnell
JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 150 MT. BETHEL RD. P.O. BOX 4917 Warren,  NJ  07059
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-09
Decision Date1991-06-04

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