• 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameENTERYX PROCEDURE KIT
Classification Nameagent, bulking, injectable for gastro-urology use
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP020006
Date Received02/11/2002
Decision Date04/22/2003
Withdrawal Date 12/27/2007
Product Code
LNM[ Registered Establishments with LNM ]
Docket Number 04M-0145
Notice Date 04/01/2004
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the enteryx procedure kit. The device is indicated for endoscopic injection into the region of the lower esophageal sphincter (les) for the treatment of gastroesophageal reflux disease (gerd) symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors.
Approval Order Approval Order
Supplements: S001 S004 S005 S008 
-
-