• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
Classification Namestent, coronary
Generic Namestent, coronary
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
PMA NumberP900043
Supplement NumberS030
Date Received11/05/2001
Decision Date04/29/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 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.