SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR
FDA premarket approval P850035/S002 · decided 1988-03-17
Approval details
- PMA number
- P850035
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1988-01-15
- Decision date
- 1988-03-17
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
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