NYS · Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
General, Plastic Surgery · 21 CFR 878.4015 · Class 2
Overview
| Product Code | NYS |
|---|---|
| Device Name | Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac) |
| Regulation | 21 CFR 878.4015 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.
Classification Rationale
Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN070002 | QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING | Quick-Med Technologies, Inc. | Feb 25, 2009 | DENG |
Top Applicants
- Quick-Med Technologies, Inc. — 1 clearance
