EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S019 · decided 1996-11-15
Approval details
- PMA number
- P850035
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1996-03-13
- Decision date
- 1996-11-15
- Days to decision
- 247 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- TRANSFER OF THE TEST ANALYSIS FOR THE DEVICE FROM CARIBBEAN BIORESEARCH LABORATORIES AND GENEVA LABORATORIES TO ELECTRO-BIOLOGY, INC., IN GUAYNABO, PUERTO RICO
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