EBI OsteoGen Implantable Bone Growth Stimulators
FDA premarket approval P790005/S060 · decided 2018-03-29
Approval details
- PMA number
- P790005
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EBI OsteoGen Implantable Bone Growth Stimulators
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2018-03-09
- Decision date
- 2018-03-29
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Addition of an alternate supplier to provide laboratory services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.
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