• 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.
 
DeviceGLUCOWATCH G2 BIOGRAPHER
Classification Nameinstrument, glucose, noninvasive technology
Generic Nameinstrument, glucose, noninvasive technology
Applicant
ANIMAS CORP.
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Supplement NumberS021
Date Received10/01/2003
Decision Date02/25/2004
Product Code
NCT
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN EXPANSION OF THE LABELING TO INCLUDE A DESCRIPTION OF PRE-TREATMENT PRODUCTS AND A METHOD TO MINIMIZE THE AFFECTS OF SKIN IRRITATION WITHOUT AFFECTING THE ACCURACY OF G2 BIOGRAPHER GLUCOSE MEASUREMENTS.
-
-