PMA P900043S021

Device: PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S021
Product code: MAF
Decision date: 2000-02-04
Generic name: STENT, CORONARY
Approval order statement: (1) the addition of a note in the Instructions for Use regarding correct prepping procedures for the balloon; (2) the addition of new width and height specifications for the inflation lumen tubing, and (3) the addition of an automated deflation test prior to product release.

Current openFDA PMA Record

Device: PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S021
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2000-02-04
Decision code: APPR
Date received: 2000-01-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: (1) the addition of a note in the Instructions for Use regarding correct prepping procedures for the balloon; (2) the addition of new width and height specifications for the inflation lumen tubing, and (3) the addition of an automated deflation test prior to product release.