EBI OsteoGen Implantable Bone Growth Stimulators
FDA premarket approval P790005/S057 · decided 2018-03-14
Approval details
- PMA number
- P790005
- Supplement
- S057
- 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
- 2018-02-13
- Decision date
- 2018-03-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Change in sterile packaging validation testing method for the SpF and EBI OsteoGen Bone Growth Stimulators.
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