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. |
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Device | ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S012 |
Date Received | 04/02/2001 |
Decision Date | 04/24/2001 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF: 1) AN OR PUMP HEATER (AP-09100) AND DRAPE (AP-09150) AS AN OPTION TO THE TRADITIONAL WATER BATH; 2) A MICROPIPETTE OR PREP KIT (AP-07004) FOR THE MEASUREMENT OF FLOW FROM THE IMPLANTABLE PUMP PRIOR TO IMPLANTATION; AND 3) ACCESSORIES TO THE INTRASPINAL KIT (AP-07009), INCLUDING AN ADDITIONAL NEEDLE AND BOTH WINGED AND TRADITIONAL CATHETER ANCHORS. |
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