HOLOGIC SAHARA CLINICAL BONE SONOMETER
FDA premarket approval P970017/S001 · decided 1999-04-29
Approval details
- PMA number
- P970017
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HOLOGIC SAHARA CLINICAL BONE SONOMETER
- Generic name
- Bone sonometer
- Applicant
- Hologic, Inc.
- Date received
- 1998-11-12
- Decision date
- 1999-04-29
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for a change in the manufacturing site to 35 Crosby Dr., Bedford, MA 01730.
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