IMAGECHECKER M1000 SYSTEM
FDA premarket approval P970058/S007 · decided 2000-05-16
Approval details
- PMA number
- P970058
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMAGECHECKER M1000 SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2000-01-28
- Decision date
- 2000-05-16
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for a change in labeling with respect to efficacy.
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