PMA P900043S007

Device: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S007
Product code: MAF
Decision date: 1997-12-19
Generic name: STENT, CORONARY
Approval order statement: Approval for the Palmaz-Schatz(TM) Crown balloon expandable stent in diameters of 3.0, 3.5, and 4.0 mm and lengths of 15, 22 and 30 mm. In addition approval for primary stenting of de novo lesions up to 25 mm in length and other modifications to the current label.

Current openFDA PMA Record

Device: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S007
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1997-12-19
Decision code: APPR
Date received: 1997-07-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Palmaz-Schatz(TM) Crown balloon expandable stent in diameters of 3.0, 3.5, and 4.0 mm and lengths of 15, 22 and 30 mm. In addition approval for primary stenting of de novo lesions up to 25 mm in length and other modifications to the current label.