Clearance Summary
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR received FDA 510(k) clearance under submission number K033130, sponsored by Osypka Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-10-31.
- Submission: K033130
- Applicant / Sponsor: Osypka Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3600
- Decision date: 2003-10-31
Classification & Regulation
This clearance is catalogued under FDA product code DTE and 21 CFR 870.3600, within the Cardiovascular review panel as a Class II device.