Microspheres And Pva Particles
Polyvinyl Alcohol Foam Embolization Particles
Indications for Use
The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for embolization of the blood supply to symptomatic uterine fibroids.
Key Specifications
- Small, flexible particles made of cross-linked polyvinyl alcohol
- Packaged dry and provided sterile in sealed vials
- Delivered to target site by catheter under fluoroscopic control
- Particle sizes: 300-500 microns and 500-710 microns
- No changes in design, dimensions, or materials
- Physically identical to predicate in design, dimensions, and materials
- Identical manufacturing process, sterilization, and packaging
- Class II device
- Regulation: 21 CFR ยง870.3300
- Product Code: NAJ
Description
Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles are small, flexible particles made of cross-linked polyvinyl alcohol, packaged dry and sterile in sealed vials for delivery via catheter under fluoroscopic control. Available sizes for symptomatic uterine fibroid treatment are 300-500 microns and 500-710 microns.