SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)
FDA premarket approval P850035/S033 · decided 2008-09-18
Approval details
- PMA number
- P850035
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2008-07-22
- Decision date
- 2008-09-18
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR A CHANGE IN THE TRADE NAME WHICH WAS PREVIOUSLY APPROVED AS: SPF-PLUS (60/W) AND SPF- PLUS (60/M). THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) AND IS INDICATED AS A SPINAL FUSING ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.
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