BIOMET EBI BONE HEALING SYSTEM
FDA premarket approval P790002/S036 · decided 2016-12-08
Approval details
- PMA number
- P790002
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMET EBI BONE HEALING SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2016-11-08
- Decision date
- 2016-12-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Qualification of an alternate supplier to provide electronic printed circuit boards (PCBs) for the three device systems. The change is being made to qualify an alternate secondary-supplier for the PCBs to complement existing approved suppliers in order to further secure the supply chain for critical components to these device systems. The following Zimmer Biomet manufacturing and distribution facility is affected by the changes: EBI Patient Care Inc., Guaynabo, Puerto Rico.
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