|
Device | ENTERYX PROCEDURE KIT |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | Boston Scientific Corp. 100 BOSTON SCIENTIFIC WAY MAILSTOP: MB-16 MARLBOROUGH, MA 01752 |
PMA Number | P020006 |
Date Received | 02/11/2002 |
Decision Date | 04/22/2003 |
Withdrawal Date
|
12/27/2007 |
Product Code |
LNM |
Docket Number | 04M-0145 |
Notice Date | 04/01/2004 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S004 S005 S008 |