Telectronics Pacing Systems, Inc. - FDA 510(k) Cleared Devices
20
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Telectronics Pacing Systems, Inc. Cardiovascular ✕
20 devices
Cleared
Jul 15, 1996
MAXIM PF MODELS 033-581/033-590
Cardiovascular
117d
Cleared
Jun 24, 1996
STERILIZATION
Cardiovascular
698d
Cleared
May 12, 1994
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
Cardiovascular
210d
Cleared
May 27, 1993
NEW LEAD INTRODUCER KITS, VARIOUS MODELS
Cardiovascular
161d
Cleared
Aug 17, 1992
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
Cardiovascular
314d
Cleared
Dec 31, 1991
UNIVERSAL TERMINAL CAP, 3.2MM
Cardiovascular
119d
Cleared
Oct 23, 1991
UNIPOLAR UPSIZING ADAPTOR
Cardiovascular
121d
Cleared
Aug 28, 1991
100 CM PERMANENT PACING LEAD MODELS
Cardiovascular
159d
Cleared
Feb 25, 1991
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
Cardiovascular
46d
Cleared
Jan 18, 1991
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
Cardiovascular
183d
Cleared
Jan 08, 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
Cardiovascular
82d
Cleared
Nov 08, 1990
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
Cardiovascular
108d
Cleared
Aug 08, 1990
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
Cardiovascular
180d
Cleared
Jun 12, 1990
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
Cardiovascular
78d
Cleared
Apr 10, 1990
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
Cardiovascular
152d
Cleared
Mar 14, 1990
OPTIMA MPT MODEL 5281E AND MODEL 5282E
Cardiovascular
78d
Cleared
Feb 22, 1990
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
Cardiovascular
132d
Cleared
Feb 05, 1990
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
Cardiovascular
46d
Cleared
Nov 14, 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
Cardiovascular
204d
Cleared
Aug 17, 1989
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
Cardiovascular
62d