IMAGECHECKER M1000 SYSTEM
FDA premarket approval P970058/S014 · decided 2002-09-13
Approval details
- PMA number
- P970058
- Supplement
- S014
- 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
- 2002-07-15
- Decision date
- 2002-09-13
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR A REVISION OF THE LABELING FOR THE DEVICE BASED ON NEW ANALYSIS OF THE ORIGINAL PMA CLINICAL DATA.
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