TRANSCAN T-SCAN 2000
FDA premarket approval P970033/S002 · decided 2000-05-03
Approval details
- PMA number
- P970033
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TRANSCAN T-SCAN 2000
- Generic name
- Imager, breast, electrical impedance
- Applicant
- Mirabel Medical Systems, Inc.
- Date received
- 1999-06-15
- Decision date
- 2000-05-03
- Days to decision
- 323 days
- Decision code
- APPR
- Product code
- NCL
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Austin, TX
- Statement
- Approval of a protocol for a postapproval study to examine the effects of the mentrual cycle on the results of the device.
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