BIOMET EBI BONE HEALING SYSTEM
FDA premarket approval P790002/S026 · decided 2011-05-19
Approval details
- PMA number
- P790002
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOMET EBI BONE HEALING SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2010-06-29
- Decision date
- 2011-05-19
- Days to decision
- 324 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR A MODIFIED, REDESIGNED, NONINVASIVE PULSED ELECTROMAGNETIC FIELD BONE GROWTH STIMULATOR SYSTEM THAT USES NEW SFLX COILS.
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