NEUROCONTROL FREEHAND SYSTEM
FDA premarket approval P950035/S008 · decided 2000-11-14
Approval details
- PMA number
- P950035
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCONTROL FREEHAND SYSTEM
- Generic name
- Stimulator, neuromuscular, implanted
- Applicant
- Biocontrol Technology, Inc.
- Date received
- 2000-07-11
- Decision date
- 2000-11-14
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- GZC
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Cleveland, OH
- Statement
- APPROVAL FOR 1) CHANGING THE MANUFACTURING SITE FOR THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR TO LEWICKI MICROELECTRONIC, GMBH; 2) ADDITION OF A RADIOGRAPHIC IDENTIFICATION LABEL TO THE IMPLANTABLE RECEIVER-STIMULATOR; AND 3) IMPLEMENTING SEVERAL DESIGN MODIFICATIONS INVOLVING THE ENCAPSULATING MATERIAL AND CIRCUITRY OF THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR.
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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 |