Pacesetter Systems - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
96 devices
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
Cleared
Sep 04, 1979
MODELS UL-804 AND BL-801 UNIPOLAR LEADS
Cardiovascular
21d
Cleared
Aug 10, 1979
PULSE GENERATOR, R WAVE DEMAND
Cardiovascular
203d
Cleared
Aug 10, 1979
BIPOLAR LEAD ADAPTOR, MODEL BA-415
Cardiovascular
192d
Cleared
Aug 10, 1979
MDL-201A & T DL-201A PULSE GENERATOR
Cardiovascular
162d
Cleared
Oct 27, 1978
PACING LEADS MODEL UL-811 AND UL-813
Cardiovascular
14d
Cleared
Sep 27, 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
Cardiovascular
41d
Cleared
Jan 30, 1978
TDL-100 B
Cardiovascular
91d
Cleared
Jan 30, 1978
MDL-201
Cardiovascular
91d
Cleared
Sep 14, 1977
UNIVERSAL LEAD ADAPTER, UA-414
Cardiovascular
16d
Cleared
Sep 14, 1977
ADAPTER A-413
Cardiovascular
16d
Cleared
Dec 23, 1976
LITHIUM IODIDE BATTERY PACEMAKER (#201)
Cardiovascular
27d
Cleared
Nov 11, 1976
MODEL 100 CARDIAC PACEMAKER
Cardiovascular
41d
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