Medtronic - Sofradim Production
FranceFDA applicant, unverified
- Devices
- 1
What Medtronic - Sofradim Production makes
Medtronic - Sofradim Production manufactures Parietene™ Flat Sheet Mesh, a surgical mesh designed for hernia repair and abdominal wall reconstruction. The product is intended for use in open surgical procedures to provide support and reinforcement to weakened or damaged tissues.
The Parietene™ Flat Sheet Mesh is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Parietene™ Flat Sheet Mesh Ref K253125
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtronic - Sofradim Production have in the registry?
The registry currently lists 1 device for Medtronic - Sofradim Production. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic - Sofradim Production's devices?
Among its 1 most recently registered device, Medtronic - Sofradim Production has devices listed in FDA 510(k) (1 device).
What risk classes do Medtronic - Sofradim Production's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medtronic - Sofradim Production's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic - Sofradim Production in the registry?
The most recently registered devices listed for Medtronic - Sofradim Production include Parietene™ Flat Sheet Mesh.