ORTHOPAK(R) BONE GROWTH STIMULATOR
FDA premarket approval P850022/S001 · decided 1986-10-08
Approval details
- PMA number
- P850022
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Other
- Trade name
- ORTHOPAK(R) BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1986-09-16
- Decision date
- 1986-10-08
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
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