SPF Implantable Spinal Fusion Stimulators
FDA premarket approval P850035/S047 · decided 2018-03-14
Approval details
- PMA number
- P850035
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPF Implantable Spinal Fusion Stimulators
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2018-02-21
- Decision date
- 2018-03-14
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Addition of an alternate supplier to provide clean room contract certification services and High Efficiency Particulate Air (HEPA) filter distribution services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.
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