PMA P970033
- Device
- TRANSCAN T-SCAN 2000
- Applicant
- Mirabel Medical Systems, Inc.
- PMA number
- P970033
- Supplement
- S002
- Product code
- NCL
- Decision date
- 2000-05-03
- Classification
- Imager, Breast, Electrical Impedance
- Generic name
- Imager, breast, electrical impedance
- Approval order statement
- Approval of a protocol for a postapproval study to examine the effects of the mentrual cycle on the results of the device.
Current openFDA PMA Record#
- Device
- TRANSCAN T-SCAN 2000
- Applicant
- Mirabel Medical Systems, Inc.
- PMA number
- P970033
- Supplement
- S002
- Product code
- NCL
- Generic name
- Imager, breast, electrical impedance
- Decision date
- 2000-05-03
- Decision code
- APPR
- Date received
- 1999-06-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of a protocol for a postapproval study to examine the effects of the mentrual cycle on the results of the device.