Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameS660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP970035
Supplement NumberS032
Date Received11/14/2001
Decision Date01/31/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic ave s660 2. 75 with discrete technology over-the-wire coronary stent system. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (<=24 mm in length) in native coronary artery or arterial bypass graft conduit with a reference diameter between 2. 2 mm and 2. 9 mm. Long-term outcome (beyond 30 days) for this implant is unknown at present.
-
-