510(k) K872779
K872779 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "PROLOG MP PULSE GENERATORS 658K AND 658T". The FDA issued a decision of Substantially Equivalent on November 4, 1987. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Pacesetter Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1987
- Date Received
- July 14, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implantable Pacemaker Pulse-Generator
- Device Class
- Class III
- Regulation Number
- 870.3610
- Review Panel
- CV
- Submission Type