Intermedics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD, BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07), CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
211
Total
201
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intermedics, Inc. Cardiovascular ✕
191 devices
Not Cleared
Dec 16, 1996
MODEL 430-07 ENDOCARDIAL PACING LEAD
Cardiovascular
439d
Cleared
Nov 04, 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE...
Cardiovascular
361d
Cleared
Aug 21, 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
Cardiovascular
77d
Cleared
Jun 19, 1996
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
Cardiovascular
197d
Cleared
Jun 18, 1996
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
Cardiovascular
151d
Cleared
Feb 27, 1996
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
Cardiovascular
137d
Cleared
Mar 15, 1995
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
Cardiovascular
624d
Cleared
Apr 29, 1993
CARDIFIX ENDOCARDIAL PACING LEAD
Cardiovascular
363d
Cleared
Jan 22, 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
Cardiovascular
217d
Cleared
Mar 17, 1992
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
Cardiovascular
41d
Cleared
Sep 18, 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
Cardiovascular
127d
Cleared
May 16, 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
Cardiovascular
65d
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