EBI OSTEOGEN BONE GROWTH STIMULATORS
FDA premarket approval P790005/S050 · decided 2013-10-03
Approval details
- PMA number
- P790005
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EBI OSTEOGEN BONE GROWTH STIMULATORS
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2013-09-06
- Decision date
- 2013-10-03
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- USE OF A NEW WATER SYSTEM MONITORING TEST METHOD.
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