Atlas FDA

MODEL 9760 PROGRAMMING SYSTEM

FDA premarket approval P890003/S007 · decided 1992-12-29

Approval details

PMA number
P890003
Supplement
S007
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MODEL 9760 PROGRAMMING SYSTEM
Generic name
implantable pacemaker Pulse-generator
Applicant
Medtronic, Inc.
Date received
1991-05-10
Decision date
1992-12-29
Days to decision
599 days
Decision code
APPR
Product code
DXY
Advisory committee
Cardiovascular
Expedited review
No
Location
Mounds View, MN

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510(k) clearances by this applicant

RecordFirmDate
VitalFlow Set with Balance™ Biosurface (K261335)Medtronic, Inc.2026-07-31
Concerto Versa™ Detachable Coil (K261866)Medtronic, Inc.2026-06-24
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195)Medtronic, Inc.2026-04-23
Retrograde Coronary Sinus Perfusion Cannulae (K253203)Medtronic, Inc.2026-02-19
Clearview Intracoronary Shunts (K253998)Medtronic, Inc.2026-01-20
Bio-Medicus Life Support Catheter and Introducer (K251831)Medtronic, Inc.2026-01-15
Concerto Versa™ Detachable Coil (K253511)Medtronic, Inc.2026-01-14
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409)Medtronic, Inc.2025-12-19