Biomet(R) EBI BONE Healing System
FDA premarket approval P790002 · decided 1979-11-06
Approval details
- PMA number
- P790002
- Trade name
- Biomet(R) EBI BONE Healing System
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1979-01-15
- Decision date
- 1979-11-06
- Days to decision
- 295 days
- Decision code
- APRL
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.