THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO
FDA premarket approval P850022/S024 · decided 2015-07-15
Approval details
- PMA number
- P850022
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2015-04-24
- Decision date
- 2015-07-15
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR A CHANGE IN THE CONDUCTOR OF THE PATIENT LEAD CABLE, BIOMET PN 1067724-().
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