PMA P900043S011

Device: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S011
Product code: MAF
Decision date: 1998-06-29
Generic name: STENT, CORONARY
Approval order statement: Approval for a redesigned taper tip configuration of the Power Grip(TM) Delivery System. The modification results in an increase in top length from 5 mm to 7 mm and a decrease in tip inner diameter from 0.020" to 0.016."

Current openFDA PMA Record

Device: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S011
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-06-29
Decision code: APPR
Date received: 1998-06-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a redesigned taper tip configuration of the Power Grip(TM) Delivery System. The modification results in an increase in top length from 5 mm to 7 mm and a decrease in tip inner diameter from 0.020" to 0.016."