PMA P850035
- Device
- SpF® Implantable Spinal Fusion Stimulators
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P850035
- Supplement
- S058
- Product code
- LOE
- Decision date
- 2024-09-20
- Generic name
- Stimulator, invasive bone growth
- Approval order statement
- Approval to supplement the device’s labeling to include 3.0 T magnetic resonance (MR) imaging conditional safety labeling claims.
Current openFDA PMA Record#
- Device
- SpF® Implantable Spinal Fusion Stimulators
- Applicant
- Ahp Eos Buyer, Inc.
- PMA number
- P850035
- Supplement
- S059
- Product code
- LOE
- Generic name
- Stimulator, invasive bone growth
- Decision date
- 2024-09-20
- Decision code
- APPR
- Date received
- 2024-02-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to supplement the device’s labeling to include 3.0 T magnetic resonance (MR) imaging conditional safety labeling claims.