• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namecatheter, percutaneous, long term, intraspinal
Applicant
SMITHS MEDICAL ASD, INC.
1265 grey fox road
st. paul, MN 55112
PMA NumberP900052
Supplement NumberS005
Date Received04/07/1998
Decision Date10/20/1998
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) the following design modifications to the current, legally marketed port-a-cath(r) ii: a smaller (25. 4mm. Based diameter, a 12. 7mm. Height, and a 8. 9mm. Septum diameter), lighter weight (5. 0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(ss) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the cath-shield catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98.
-
-