Premarket Approval (PMA)

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.

• Device: GEM MODEL 7227 IMPLANTABLE DEVICE
• Generic Name: Pump, infusion, implanted, programmable
• Applicant: Intera Oncology; 180 Wells Ave., Suite 300a; Newton, MA 02459
• PMA Number: P890055
• Supplement Number: S021
• Date Received: 08/06/2007
• Decision Date: 09/07/2007
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX, NORTHBOROUGH, MASSACHUSETTS.