OsteoGen Surigically Implantable Bone Growth Stimulators
FDA premarket approval P790005/S066 · decided 2019-07-18
Approval details
- PMA number
- P790005
- Supplement
- S066
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OsteoGen Surigically Implantable Bone Growth Stimulators
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2019-06-21
- Decision date
- 2019-07-18
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Qualify and approve an alternate, proposed supplier, Vesta Intermediate Funding d/b/a Lubrizol Life Sciences to provide a silicone over-extruded cable to manufacture and assemble implantable stimulator leads for the subject devices (OsteoGen Surigically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators).
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