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.
 
DeviceFEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantMORRIS INNOVATIVE RESEARCH INC
907 W.SECOND ST
BLOOMINGTON, IN 47403
PMA NumberP050043
Supplement NumberS005
Date Received05/12/2011
Decision Date07/11/2011
Product Code MGB 
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: ADDING A CUFF STABILIZER SHEATH, MODIFYING THE SUTURE INDICATOR KNOTS AND UPDATING LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FISH- SP ADVANCED COMPRESSION DEVICE AND IS INDICATED FOR "...FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, 7 OR 8 FRENCH PROCEDURAL SHEATHS."
-
-