Pacesetter Systems - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
87 devices
Cleared
Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
Cardiovascular
77d
Cleared
Aug 06, 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
Cardiovascular
37d
Cleared
Jun 02, 1982
PACEMAKER UNIPOLAR ADAPTER
Cardiovascular
8d
Cleared
Jun 02, 1982
PACEMAKER CONNECTOR PLUG
Cardiovascular
8d
Cleared
Jun 02, 1982
PACEMAKER 445 ADAPTER
Cardiovascular
8d
Cleared
May 07, 1982
PROGRAMMALITH II, #225 & 226
Cardiovascular
28d
Cleared
Dec 02, 1981
DIRECTIONAL BOOT
Cardiovascular
26d
Cleared
Dec 02, 1981
VITATRON INSERT
Cardiovascular
26d
Cleared
Dec 02, 1981
ELECTRODE TERMINAL CAP
Cardiovascular
26d
Cleared
Dec 02, 1981
TEST MAGNET
Cardiovascular
26d
Cleared
Dec 02, 1981
ADAPTING SLEEVE
Cardiovascular
26d
Cleared
Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
Cardiovascular
310d
Cleared
Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
Cardiovascular
298d
Cleared
Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
Cardiovascular
22d
Cleared
Oct 29, 1981
MODEL 841 ENDOCARDIAL TINED LEAD
Cardiovascular
22d
Cleared
Aug 13, 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
Cardiovascular
105d
Cleared
Apr 23, 1981
PACEMAKER LEAD ADAPTER
Cardiovascular
52d
Cleared
Mar 13, 1981
ELECTRODE, PACEMAKER PERMANENT
Cardiovascular
10d
Cleared
Oct 31, 1980
PACEPATH MODEL 810
Cardiovascular
137d
Cleared
Oct 31, 1980
PACEMAKER LEAD ADAPTOR MODEL 431
Cardiovascular
28d
Cleared
Oct 23, 1980
PACEPATH MODEL 819
Cardiovascular
129d
Cleared
Oct 23, 1980
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM
Cardiovascular
121d
Cleared
Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
Cardiovascular
38d
Cleared
Aug 27, 1980
VIVALITH 5, - MDL-201A & TDL-201A
Cardiovascular
30d
Cleared
Sep 20, 1979
MODEL 221 PROGRAMALITH PULSE GENERATOR
Cardiovascular
136d
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