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. |
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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 | S001 |
Date Received | 11/10/2003 |
Decision Date | 11/26/2003 |
Withdrawal Date
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12/27/2007 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFY THE METHOD OF CAPPING THE VIALS OF ENTERYX AND DMSO AND MODIFY THE OVERLAYING PROCESS. |
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