NEUROCONTROL FREEHAND SYSTEM
FDA premarket approval P950035/S004 · decided 1999-05-18
Approval details
- PMA number
- P950035
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEUROCONTROL FREEHAND SYSTEM
- Generic name
- Stimulator, neuromuscular, implanted
- Applicant
- Biocontrol Technology, Inc.
- Date received
- 1999-04-07
- Decision date
- 1999-05-18
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- GZC
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Cleveland, OH
- Statement
- Approval for the following: 1) Changing the manufacturing site for the Epimysial Probe, Anode Plate, and Epimysial Electrode to Lewicki Microelectronic, GmbH; 2) Changing the site for packaging and sterilization of the Freehand System Electrode Positioning Kit and Epimysial Electrode to Lewicki Microelectronic , GmbH; 3) Addition of two paper measuring tapes to the Electrode Positioning Kit; 4) Changing the materila used to support the Anode Plate and the coating over this material; 5) Changing
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 |