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: HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM
• Classification Name: stent, coronary
• Generic Name: coronary stent and delivery system
• Applicant: CORDIS CORP.
• PMA Number: P900043
• Supplement Number: S031
• Date Received: 12/21/2001
• Decision Date: 05/10/2002
• 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 hepacoat on bx sonic balloon-expandable stent otw delivery system. The device, as modified, is 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 in length) 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.