NEUROCONTROL FREEHAND II SYSTEM
FDA premarket approval P950035/S009 · decided 2002-01-18
Approval details
- PMA number
- P950035
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEUROCONTROL FREEHAND II SYSTEM
- Generic name
- Stimulator, neuromuscular, implanted
- Applicant
- Biocontrol Technology, Inc.
- Date received
- 2000-12-22
- Decision date
- 2002-01-18
- Days to decision
- 392 days
- Decision code
- APPR
- Product code
- GZC
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Cleveland, OH
- Statement
- APPROVAL FOR THE UNIVERSAL EXTERNAL CONTROLLER (UEC), REVISED FREEHAND CLINICIAN PROGRAMMING INTERFACE SOFTWARE, VERSION 5.0, WHICH ARE USED TO OPERATE AND PROGRAM THE FREEHAND IMPLANTABLE-RECEIVER STIMULATOR, AND SUBSEQUENT CHANGES TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FREEHAND II SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |