NEUROCONTROL FREEHAND SYSTEM
FDA premarket approval P950035/S005 · decided 2000-01-13
Approval details
- PMA number
- P950035
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEUROCONTROL FREEHAND SYSTEM
- Generic name
- Stimulator, neuromuscular, implanted
- Applicant
- Biocontrol Technology, Inc.
- Date received
- 1999-11-24
- Decision date
- 2000-01-13
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- GZC
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Cleveland, OH
- Statement
- 1)Replace the MRI warning in the package insert,clinician manual and user manual with a precaution statement that provides information for performing MRI scanning of patients with the Freehand System; 2) modify the IDE card to include wording advising NeuroControl be contacted for information prior to MRI scanning; 3) "MRI Information Sheet" which provides guidance for MRI scanning will be provided upon request.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 (K974475) | Biocontrol Technology, Inc. | 1998-03-02 |
| THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 (K960350) | Biocontrol Technology, Inc. | 1996-04-15 |