ICAD
FDA premarket approval P010038/S002 · decided 2002-11-20
Approval details
- PMA number
- P010038
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ICAD
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2002-10-28
- Decision date
- 2002-11-20
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR A DEVICE NAME CHANGE FROM "MAMMOREADER" TO "ICAD."
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