• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameINFUSAID IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantARROW INTL., INC.
PMA NumberP800036
Supplement NumberS034
Date Received09/04/1997
Decision Date12/19/1997
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 No
Approval Order Statement 
Approval for the use of arrow 22 gauge non-coring (hubber) needles (catalog #s ap-04009, ap-04011, and ap-04030) to access infusaid model 400 infusion pumps.
-
-