OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR
FDA premarket approval P790005/S040 · decided 1998-05-01
Approval details
- PMA number
- P790005
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1998-04-09
- Decision date
- 1998-05-01
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for the addition of a 8-cm mesh cathode to be used with the EBI OsteoGen(TM) Bone Growth Stimulator.
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