EBI BONE HEALING SYSTEM(R)
FDA premarket approval P790002/S016 · decided 1996-04-09
Approval details
- PMA number
- P790002
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EBI BONE HEALING SYSTEM(R)
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1995-06-02
- Decision date
- 1996-04-09
- Days to decision
- 312 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- CHANGES TO LABELING INCLUDING THE ADDITION OF INFORMATION REGARDING "TREATMENT COMPLETION," (AFFECTS PHYSICIAN INSTRUCTION MANUAL), A DESCRIPTION OF THE PMA POPULATION AND ORIGINAL AND FOUR YEAR SUCCESS RATES (AFFECTS PHYSICIAN INSTRUCTION AND PATIENT MANUALS) AND THE ADDITION OF A CONTRAINDICATION FOR PATEINTS WEARING IMPALNTABLE DEFIBRILLATORS (AFFECTS PHYSICIAN INSTRUCTION MANUAL)
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