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.
 
DevicePROSTAR XL 8 AND 10 FRENCH, CLOSER, CLOSER S, PERCLOSE AT, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER
Generic NameDevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063
PMA NumberP960043
Supplement NumberS047
Date Received07/08/2003
Decision Date09/02/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD WORDING IN THE PRECAUTIONS SECTION IN THE LABELING, INFORMING THE USER THAT REACCESS/REPUNCTURE OF THE FEMORAL ARTERY WITH THE ABOVE LISTED DEVICES IS NOT RESTRICTED FOR PATIENTS WHO HAVE PREVIOUSLY RECEIVED THESE DEVICES IN EARLIER ARTERIOTOMY REPAIRS.
-
-