EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR
FDA premarket approval P790005/S044 · decided 2005-06-03
Approval details
- PMA number
- P790005
- Supplement
- S044
- Supplement type
- Normal 180 Day Track
- Trade name
- EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2004-06-09
- Decision date
- 2005-06-03
- Days to decision
- 359 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR A MODIFIED, SMALLER VERSION OF THE DEVICES.
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