Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM
• Classification Name: stent, coronary
• Generic Name: intravascular coronary stent
• Applicant: ABBOT LABORATORIES
• PMA Number: P000011
• Supplement Number: S006
• Date Received: 02/01/2002
• Decision Date: 07/26/2002
• Product Code: MAF [ Registered Establishments with MAF ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the addition of the 7 mm stent length (in all diameters, 2. 0, 2. 25 and 2. 5 mm) and 2. 25 mm diameter biodivysio sv otw product to previously approved stent lengths of 10, 15 and 18 mm (supplement 3). The device, as modified, will be marketed under the trade name biodivysio sv otw and is indicated for: "improving coronary luminal diameter in subjects experiencing abrupt closure or threatened abrupt vessel closure following percutaneous revascularization of de novo or non in-stent restenotic native coronary artery lesions (length of lesion and/or dissection <=25 mm) with reference vessel diameter ranging from >=2. 0 mm to <=2. 75 mm by visual estimate. Long-term outcome (beyond 6 months) for this implant is unknown at present.