OSTEOGEN(R) D40 IMPLANTABLE BONE GROWTH STIMULATOR
FDA premarket approval P790005/S042 · decided 2000-05-10
Approval details
- PMA number
- P790005
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OSTEOGEN(R) D40 IMPLANTABLE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2000-04-11
- Decision date
- 2000-05-10
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for a two lead OsteoGen Implantable Bone Growth Stimulator.
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