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.
 
DeviceGIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
Generic NameFILTER, INTRAVASCULAR, CARDIOVASCULAR
Regulation Number870.3375
ApplicantCook, Inc.
P.O. Box 489
Bloomington, IN 47402
PMA NumberP850049
Supplement NumberS006
Date Received10/07/1998
Decision Date12/21/1998
Reclassified Date05/01/2000
Product Code DTK 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change to the packaging.
-
-