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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameSURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP890055
Supplement NumberS025
Date Received12/11/2007
Decision Date10/10/2008
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for: 1) a new manufacturing facility, codman neurosciences, sarl, lelocle, switzerland and 2) the additional device accessories for the codman 3000 constant flow implantable infusion pump ¿ surestream intraspinal catheter kit (60-2918) & surestream replacement connector and strain relief sleeve (60-2950).
-
-