Low Electric Field Generator For Pancreatic Cancer Treatment
SHC · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SHC
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
SU
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
Intended to treat pancreatic cancer through delivery of low electric fields in patients receiving concomitant systemic therapies or other standard of care treatment(s)