Pump, Infusion, Implanted, Programmable
Pump, Infusion, Implanted, Programmable is a fully implantable, electronically programmable drug delivery pump surgically placed within the body to deliver precise, adjustable doses of medication directly into a targeted site such as the intrathecal space, used for management of chronic pain, spasticity, or cancer chemotherapy. This is the highest risk FDA Class 3 device, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LKK; no regulation number has been assigned. This device is an implant.
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Basic Information
- Product Code
- LKK
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- HO
- Submission Type
- 2
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.