NEUROCONTROL FREEHAND SYSTEM(R)
FDA premarket approval P950035/S002 · decided 1998-07-28
Approval details
- PMA number
- P950035
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEUROCONTROL FREEHAND SYSTEM(R)
- Generic name
- Stimulator, neuromuscular, implanted
- Applicant
- Biocontrol Technology, Inc.
- Date received
- 1998-06-29
- Decision date
- 1998-07-28
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- GZC
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Cleveland, OH
- Statement
- Application submitted to inform the Agency of the potential for device malfunction induced by electrostatic discharge and the changes being implementing to address the effects of ESD on the device. The Special Supplement requested approval for revised manufacturing procedures, revised labeling for the clinician, and revised patient labeling.
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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 |