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.
 
DeviceCLOSER S(TM) 6FR. SMC DEVICE
ApplicantABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063
PMA NumberP960043
Supplement NumberS026
Date Received08/31/2000
Decision Date09/29/2000
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM. THE DEVICE, AS MODIFIED, IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS. THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (5 METERS OR 16 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS IN THE DEVICE LABELING).
-
-