| 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. |
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| Trade Name | ENTERYX PROCEDURE KIT |
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| Classification Name | agent, bulking, injectable for gastro-urology use |
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| Applicant | BOSTON SCIENTIFIC CORP. |
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| PMA Number | P020006 |
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| Date Received | 02/11/2002 |
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| Decision Date | 04/22/2003 |
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Withdrawal Date
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12/27/2007 |
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| Product Code | |
| Docket Number | 04M-0145 |
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| Notice Date | 04/01/2004 |
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| Advisory Committee |
Gastroenterology/Urology |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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| Supplements: |
S001 S004 S005 S008 |
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