HYPERTHERMIA SYSTEM 100 A
FDA premarket approval P880064/S002 · decided 1997-09-17
Approval details
- PMA number
- P880064
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYPERTHERMIA SYSTEM 100 A
- Generic name
- Applicator, hyperthermia, superficial, rf/microwave
- Applicant
- Medifocus, Inc.
- Date received
- 1997-07-15
- Decision date
- 1997-09-17
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LNC
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Columbia, MD
- Statement
- Approval for a design change to enhance the heat focusing capabilities of the Microfocus 1000 Hyperthermia System.
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