PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS
FDA premarket approval P850007/S020 · decided 2000-03-09
Approval details
- PMA number
- P850007
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 1997-08-25
- Decision date
- 2000-03-09
- Days to decision
- 927 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval to modify the device labeling to include Patient Registry data in addition to the original data contained in the PMA
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