Bag, Polymeric Mesh, Pacemaker
The Polymeric Mesh Pacemaker Bag is a cardiovascular implantable accessory used to house and stabilize an implanted pacemaker generator within the body, helping to maintain its position and protect surrounding tissue from direct contact with the device. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DSW and it is regulated under 21 CFR 870.3650 within the Cardiovascular medical specialty. This device is flagged as an implant.
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Basic Information
- Product Code
- DSW
- Device Class
- FDA class 1
- Regulation Number
- 870.3650
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.