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 | AMS 800 URINARY CONTROL SYSTEM |
Generic Name | Device, incontinence, mechanical/hydraulic |
Regulation Number | 876.5280 |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P000053 |
Supplement Number | S024 |
Date Received | 05/08/2009 |
Decision Date | 07/06/2009 |
Product Code |
EZY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF A NEW, SMALLER 3.5 CM CUFF SIZE TO BE USED AS A COMPONENT OF THE EXISTING AMS 800 URINARY CONTROL SYSTEM, AND FOR RELATED LABELING CHANGES. |
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