OEE · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OEE
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
N
Implant
N
Third-party review
N
Definition
As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.