SpF® Implantable Spinal Fusion Stimulator
FDA premarket approval P850035 · decided 1987-04-30
Approval details
- PMA number
- P850035
- Trade name
- SpF® Implantable Spinal Fusion Stimulator
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1985-05-31
- Decision date
- 1987-04-30
- Days to decision
- 699 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.