BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR
FDA premarket approval P850022/S014 · decided 2003-05-23
Approval details
- PMA number
- P850022
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2003-04-23
- Decision date
- 2003-05-23
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR ADDITIONAL LABELING TO EMPHASIZE THE PROPER USE OF THE DEVICE ELECTRODES.
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