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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.
 
DeviceAmbicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS145
Date Received03/12/2018
Decision Date04/06/2018
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 ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition to the labeling of adverse events (bleeding, exposure to biohazardous material, hemorrhage, improper size, pain, perforation, injury, prolonged procedure, supersonic transporter, unretrieved device fragment).
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