PMA P900043S008

Device: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S008
Product code: MAF
Decision date: 1998-06-08
Generic name: STENT, CORONARY
Approval order statement: Approval for the indication of treatment of restenotic native coronary artery lesions with a reference diameter in the range of 3-4 mm, and modifications to the current label that include addition of the Stars Trial results to the clinical summary section.

Current openFDA PMA Record

Device: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P900043
Supplement: S008
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-06-08
Decision code: APPR
Date received: 1997-12-15
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the indication of treatment of restenotic native coronary artery lesions with a reference diameter in the range of 3-4 mm, and modifications to the current label that include addition of the Stars Trial results to the clinical summary section.