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: BX VELOCITY(TM) STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM
• Classification Name: stent, coronary
• Generic Name: coronary stent and delivery system
• Applicant: CORDIS
• PMA Number: P900043
• Supplement Number: S025
• Date Received: 07/10/2000
• Decision Date: 02/02/2001
• Product Code: MAF [ Registered Establishments with MAF ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a new indication (i. E. , de novo and restenotic lesions) and additional stent diameters (i. E. , 4. 5 and 5. 0 mm) for the bx velocity(tm) stent with raptor(tm) over-the-wire delivery system. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (<=30 mm inlength) in native coronary arteries with reference diameters ranging from 3. 0 mm to 5. 0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (<=30 mm in length) with reference diameters in the range of 2. 25 mm to 4. 00 mm. The 2. 25 mm, 2. 5 mm, and 2. 75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4. 5 and 5. 0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.