ORTHOPAK(R) BONE GROWTH STIMULATOR
FDA premarket approval P850022/S007 · decided 1994-03-09
Approval details
- PMA number
- P850022
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOPAK(R) BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1992-09-24
- Decision date
- 1994-03-09
- Days to decision
- 531 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
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