Clearance Summary
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD received FDA 510(k) clearance under submission number K894494, sponsored by Biotronik, GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-10-17.
- Submission: K894494
- Applicant / Sponsor: Biotronik, GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1989-10-17
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.