EBI BONE HEALING SYSTEM(R)
FDA premarket approval P790002/S018 · decided 1997-06-11
Approval details
- PMA number
- P790002
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EBI BONE HEALING SYSTEM(R)
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1997-02-10
- Decision date
- 1997-06-11
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THE FLX(R) COILETTE WHICH WILL BE USED TO DELIVERY THE APPROVED REPETITIVE PULSE BURST SIGNAL PRODUCED BY THE EBI BONE HEALING SYSTEM MODEL 1200. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI FLX COILETTE TO BE USED WITH THE EBI BONE HEALING SYSTEM MODEL 1200 WHICH IS INDICATED FOR NONUNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDARTHROSES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.