SPF SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S028 · decided 2000-06-23
Approval details
- PMA number
- P850035
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPF SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2000-05-30
- Decision date
- 2000-06-23
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR A CHANGE FROM A LITHIUM IODINE BATTERY (CRC 1935M) TO A LITHIUM MANGANESE BATTERY (RENATA, CR-2032AMT207-1) IN THE SPF(R) 2T, 4T AND XLIIB SPINAL FUSION STIMULATORS.
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