GZB · Class II · 21 CFR 882.5880

FDA Product Code GZB: Stimulator, Spinal-cord, Implanted (pain Relief)

Leading manufacturers include Medtronic Vascular, Advanced Neuromodulation Systems and Neuromed, Inc..

139
Total
139
Cleared
117d
Avg days
1978
Since
139 devices
73–96 of 139
Cleared May 17, 1996
DUALSCREEN
K955291
Medtronic Vascular
Neurology · 183d
Cleared Nov 27, 1995
MODEL NOS. 7495 AND 501826 EXTENSIONS
K954886
Medtronic Vascular
Neurology · 151d
Cleared Oct 13, 1995
PAIN DOC
K941342
Regulatory & Marketing Services, Inc.
Neurology · 598d
Cleared Aug 30, 1995
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
K952459
Medtronic Vascular
Neurology · 96d
Cleared Apr 12, 1995
MODEL 3470 X-TREL RF RECEIVER
K943537
Medtronic Vascular
Neurology · 264d
Cleared Feb 14, 1995
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
K934065
Medtronic Vascular
Neurology · 543d
Cleared Jan 30, 1995
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
K950127
Medtronic Vascular
Neurology · 18d
Cleared Jan 11, 1995
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
K945103
Medtronic Vascular
Neurology · 85d
Cleared Dec 15, 1994
NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
K930536
Neuromed, Inc.
Neurology · 687d
Cleared Dec 12, 1994
NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
K930498
Neuromed, Inc.
Neurology · 679d
Cleared Jul 18, 1994
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
K940416
Medtronic Vascular
Neurology · 171d
Cleared Jul 11, 1994
NEUROLOGICAL LEAD ACCESSORIES
K936099
Medtronic Vascular
Neurology · 201d
Cleared Jun 14, 1994
TEMPORARY SCREENING LEAD/CATHETER KIT
K934938
Medtronic Vascular
Neurology · 239d
Cleared May 04, 1994
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
K932202
Medtronic Vascular
Neurology · 363d
Cleared Feb 03, 1994
MEDTRONIC MODEL 3625 SCREENER SYSTEM
K932948
Medtronic Vascular
Neurology · 231d
Cleared Feb 02, 1994
INTRODE INT-8
K930242
Neuromed, Inc.
Neurology · 379d
Cleared May 05, 1993
NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
K921319
Neuromed, Inc.
Neurology · 412d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K923931
Medtronic Vascular
Neurology · 225d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
K924522
Medtronic Vascular
Neurology · 191d
Cleared Nov 05, 1992
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
K923567
Medtronic Vascular
Neurology · 111d
Cleared Jul 07, 1992
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
K921558
Medtronic Vascular
Neurology · 97d
Cleared Feb 07, 1992
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
K913993
Medtronic Vascular
Neurology · 154d
Cleared Jan 22, 1992
MEDTRONIC MODEL 3586 RESUME LEAD
K913934
Medtronic Vascular
Neurology · 141d
Cleared Dec 23, 1991
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K914433
Medtronic Vascular
Neurology · 80d