BSD 1000 HYPERTHERMIA SYSTEM
FDA premarket approval P820088/S003 · decided 1984-10-29
Approval details
- PMA number
- P820088
- Supplement
- S003
- Trade name
- BSD 1000 HYPERTHERMIA SYSTEM
- Generic name
- System, rf/microwave hyperthermia, cancer treatment
- Applicant
- Pyrexar Medical, Inc.
- Date received
- 1984-09-04
- Decision date
- 1984-10-29
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LOC
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Salt Lake City, UT
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.