BSD 1000 HYPERTHERMIA SYSTEM
FDA premarket approval P820088/S014 · decided 1991-11-26
Approval details
- PMA number
- P820088
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BSD 1000 HYPERTHERMIA SYSTEM
- Generic name
- System, rf/microwave hyperthermia, cancer treatment
- Applicant
- Pyrexar Medical, Inc.
- Date received
- 1991-09-23
- Decision date
- 1991-11-26
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LOC
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Salt Lake City, UT
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