PMA P910030S008

Device: GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
Applicant: Cook, Inc.
PMA number: P910030
Supplement: S008
Product code: MAF
Decision date: 1998-05-05
Generic name: STENT, CORONARY
Approval order statement: Approval for a labeling change in the Instructions for Use ("Technical Information and Suggested Instructions for Placement") of the GR II(TM) Coronary Stent.

Current openFDA PMA Record

Device: GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
Applicant: Cook, Inc.
PMA number: P910030
Supplement: S008
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-05-05
Decision code: APPR
Date received: 1998-01-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling change in the Instructions for Use ("Technical Information and Suggested Instructions for Placement") of the GR II(TM) Coronary Stent.