Last synced on 27 January 2023 at 11:04 pm

Rf/Microwave Hyperthermia System, Cancer Treatment

Page Type
Product Code
Definition
Used in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors.
Physical State
Hyperthermia System
Technical Method
Hyperthermia
Target Area
Cervical carcinoma
Review Panel
Obstetrical and Gynecological
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PAS to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Rf/Microwave Hyperthermia System, Cancer Treatment

Page Type
Product Code
Definition
Used in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors.
Physical State
Hyperthermia System
Technical Method
Hyperthermia
Target Area
Cervical carcinoma
Review Panel
Obstetrical and Gynecological
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code PAS to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.