PMA P000011

Device: PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P000011
Product code: MAF
Decision date: 2003-12-08
Generic name: STENT, CORONARY
Approval order statement: APPROVAL FOR THE ADDITION OF AN 8 MM STENT IN DIAMETERS OF 3.0, 3.5, AND 4.0 MM FOR THE BIODIVYSIO OC OTW SYSTEM.

Current openFDA PMA Record

Device: PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P000011
Supplement: S009
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2003-12-08
Decision code: APPR
Date received: 2003-07-01
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF AN 8 MM STENT IN DIAMETERS OF 3.0, 3.5, AND 4.0 MM FOR THE BIODIVYSIO OC OTW SYSTEM.