BIOMET EBI BONE HEALING
FDA premarket approval P790002/S031 · decided 2014-04-30
Approval details
- PMA number
- P790002
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOMET EBI BONE HEALING
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2014-02-07
- Decision date
- 2014-04-30
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR MINOR MODIFICATIONS TO THE SOFTWARE TO PREVENT A CANNOT TREAT ERROR.
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