PMA P020047S042

Device: MULTI-LINK 8 CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S042
Product code: MAF
Decision date: 2012-04-03
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: APPROVAL FOR CHANGES TO THE MULTI-LINK 8 CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) TO ALIGN/UPDATE THE IFU VERBIAGE WITH A RECENTLY APPROVED CORONARY STENT SYSTEM.

Current openFDA PMA Record#

Device: MULTI-LINK 8 CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S042
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2012-04-03
Decision code: APPR
Date received: 2012-02-03
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE MULTI-LINK 8 CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) TO ALIGN/UPDATE THE IFU VERBIAGE WITH A RECENTLY APPROVED CORONARY STENT SYSTEM.