SPINALPAK(R) STIMULATOR
FDA premarket approval P850022/S009 · decided 1999-09-24
Approval details
- PMA number
- P850022
- Supplement
- S009
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPINALPAK(R) STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1997-03-13
- Decision date
- 1999-09-24
- Days to decision
- 925 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for SpinalPak Bone Growth Stimulator. The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
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