EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR
FDA premarket approval P790005/S041 · decided 1998-07-24
Approval details
- PMA number
- P790005
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1998-06-24
- Decision date
- 1998-07-24
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for revision of the indications and usage section ofthe labeling to include the definitiono f nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.