Clearance Summary
28 UNIPOLAR AND BIPOLAR PULSE GENERATORS received FDA 510(k) clearance under submission number K790452, sponsored by Edwards Pacemaker Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-05-08.
- Submission: K790452
- Applicant / Sponsor: Edwards Pacemaker Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1979-05-08
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.