SPF IMPLANTABLE BONE GROWTH STIMULATOR
FDA premarket approval P850035/S025 · decided 2000-09-27
Approval details
- PMA number
- P850035
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPF IMPLANTABLE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2000-03-31
- Decision date
- 2000-09-27
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR REVISED LABELING BASED ON THE FINDINGS OF THE POST-APPROVAL STUDY FOR THE SPF(R) IMPLANTABLE BONE GROWTH STIMULATOR.
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