EBI BONE HEALING SYSTEM(R)
FDA premarket approval P790002/S009 · decided 1987-06-23
Approval details
- PMA number
- P790002
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EBI BONE HEALING SYSTEM(R)
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1987-06-11
- Decision date
- 1987-06-23
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
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