SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR
FDA premarket approval P850035/S012 · decided 1991-08-12
Approval details
- PMA number
- P850035
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1991-05-10
- Decision date
- 1991-08-12
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
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