PMA P900043S023

Device: PALMAZ-SCHATZ(R) MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY(TM) OVER THE WIRE DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S023
Product code: MAF
Decision date: 2000-05-24
Generic name: STENT, CORONARY
Approval order statement: Approval for modifications to the labeling for the PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent with Dynasty Over-the-Wire Delivery System to include 6-month data.

Current openFDA PMA Record

Device: PALMAZ-SCHATZ(R) MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY(TM) OVER THE WIRE DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S023
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2000-05-24
Decision code: APPR
Date received: 2000-02-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the labeling for the PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent with Dynasty Over-the-Wire Delivery System to include 6-month data.