• 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
p.o. box 9018
temecula, CA 92589-9018
PMA NumberP020047
Supplement NumberS022
Date Received07/01/2010
Decision Date08/31/2010
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 2. 25mm diameter stent size as part of the multi-link 8 coronary stent system. The device, as modified, will be marketed under the trade name multi-link 8 sv coronary stent system and is indicated for patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length <=25 mm) with reference vessel diameters of 2. 25mm.