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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, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™, AMS Ambicor Inflatable Pe
Generic NameProsthesis, penis, inflatable
Regulation Number876.3350
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberN970012
Supplement NumberS196
Date Received03/24/2023
Decision Date09/20/2023
Product Code JCW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) an update to the AMS 700 product labeling to include an alternative implant location for the AMS 700 reservoir. The AMS 700 reservoir is a component of the AMS 700 system and is available with or without the drug treatment known as InhibiZone; and 2) an update to the AMS 700 product labeling and the AMS Ambicor product labeling to include new parameters for safe magnetic resonance scanning of a patient implanted with an AMS 700 system or an AMS Ambicor device.
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