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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 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberN970012
Supplement NumberS096
Date Received07/16/2013
Decision Date08/14/2013
Product Code JCW 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS OF THE OPERATING ROOM MANUAL BY ADDITIONAL EMPHASIS, INSTRUCTIONS, AND INFORMATION FOR TUBE INFLATION/DEFLATION ISSUES IN THE TROUBLESHOOTING, SURGICAL, AND POST-OPERATIVE PROCEDURE SUB-SECTIONS.
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