SAW · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SAW
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
The combination product consists of an optical imaging agent for injection, and a fluorescence imaging device. The product is intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The imaging device is used with the imaging drug for fluorescence imaging of the lumpectomy cavity.