PHYSIO-STIM AND SPINAL-STIM
FDA premarket approval P850007/S033 · decided 2014-08-27
Approval details
- PMA number
- P850007
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PHYSIO-STIM AND SPINAL-STIM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2014-08-01
- Decision date
- 2014-08-27
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- PROCESS CHANGE FOR THE BONE GROWTH STIMULATOR DEVICES.
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