|
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 |
Supplement Number | S004 |
Date Received | 04/09/2004 |
Decision Date | 05/26/2004 |
Withdrawal Date
|
12/27/2007 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT LIFE SCIENCE OUTSOURCING, BREA, CALIFORNIA. FINAL ASSEMBLY OF THE ENTERYX INJECTOR AND THE KITTING PROCEDURES WILL BE PERFORMED AT THIS FACILITY. |
Post-Approval Study | Show Report Schedule and Study Progress |