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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 INFLATABLE PENILE PROSTHESIS
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS103
Date Received01/09/2015
Decision Date04/07/2015
Product Code JCW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
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 AMS 800 INHIBIZONE (IZ) LABELING TO MATCH THE AMS 700 IZ LABELING; MODIFY TERMS FOR CLARITY AND ACCURACY, AND MODIFY THE LABELING TO CLARIFY THE UPPER QUANTITY OF IZ COATING ON THE DEVICE.
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