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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP)
Generic NameDevice, impotence, mechanical/hydraulic
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS110
Date Received07/15/2015
Decision Date08/04/2015
Product Code FHW 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE INSTRUCTIONS FOR USE TO EXPAND THE ADVERSE DEVICE EFFECTS INFORMATION TO REFLECT NEWLY ACQUIRED INFORMATION.
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