EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S024 · decided 1999-04-07
Approval details
- PMA number
- P850035
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1998-07-06
- Decision date
- 1999-04-07
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for labeling changes stating the device was MR Safe.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.