BIOMET BHS- MINI
FDA premarket approval P790002/S025 · decided 2008-01-17
Approval details
- PMA number
- P790002
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOMET BHS- MINI
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2007-04-06
- Decision date
- 2008-01-17
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS RELATED TO TWO NEW COILS, A NEW BATTERY TYPE, A NEW COIL APPLICATION METHOD, AND A REDESIGNED CONTROL BOX. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIOMET BHS-MINI AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSIS IN THE APPENDICULAR SYSTEM.
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