CERVICAL-STIM
FDA premarket approval P030034/S008 · decided 2015-08-26
Approval details
- PMA number
- P030034
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERVICAL-STIM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2015-07-28
- Decision date
- 2015-08-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- IMPLEMENTATION OF AN ALTERNATE MACHINE TO PRODUCE TRANSDUCER COILS (CERVICAL-STIM ONLY) AND REMOVE REDUNDANT INSPECTION OF VARIOUS DEVICE COMPONENTS.
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