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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP970061
Supplement NumberS009
Date Received07/17/2000
Decision Date08/22/2000
Withdrawal Date07/17/2007
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC/SCIMED, INC., PLYMOUTH, MINNESOTA 55442 AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA, WILLOWBROOK, ILLINOIS 60521.
-
-