SpF® Implantable Spinal Fusion Stimulators
FDA premarket approval P850035/S059 · decided 2024-09-20
Approval details
- PMA number
- P850035
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SpF® Implantable Spinal Fusion Stimulators
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2024-02-08
- Decision date
- 2024-09-20
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval to supplement the devices labeling to include 3.0 T magnetic resonance (MR) imaging conditional safety labeling claims.
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