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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.
 
DeviceIMPLANTABLE DRUG DELIVERY SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
65 William St.
Suite 2000
Wellesley, MA 02481
PMA NumberP800036
Supplement NumberS037
Date Received11/24/2010
Decision Date12/22/2010
Withdrawal Date03/12/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.
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