Pacesetter Systems - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pacesetter Systems Cardiovascular ✕
87 devices
Cleared
Aug 28, 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
Cardiovascular
176d
Cleared
Jul 17, 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
Cardiovascular
63d
Cleared
Jun 25, 1990
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
Cardiovascular
143d
Cleared
Apr 20, 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
Cardiovascular
73d
Cleared
Dec 20, 1989
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
Cardiovascular
103d
Cleared
Jun 05, 1989
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
Cardiovascular
70d
Cleared
Mar 28, 1989
VS-1 MODEL NUMBER 251K PULSE GENERATOR
Cardiovascular
96d
Cleared
Mar 22, 1989
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
Cardiovascular
47d
Cleared
Feb 10, 1989
AFP MODEL 262T PULSE GENERATOR
Cardiovascular
92d
Cleared
Sep 14, 1988
PROLOG MP 658M PULSE GENERATOR
Cardiovascular
55d
Cleared
Feb 02, 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
Cardiovascular
110d
Cleared
Nov 04, 1987
PROLOG MP PULSE GENERATORS 658K AND 658T
Cardiovascular
113d
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