Atlas FDA

OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR

FDA 510(k) clearance K894185 · decided 1989-08-17

Clearance details

K-number
K894185
Device name
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
Applicant
Telectronics Pacing Systems, Inc.
Decision
Substantially Equivalent
Date received
1989-06-16
Decision date
1989-08-17
Days to decision
62 days
Clearance type
Traditional
Product code
DXY
Device class
3
Regulation number
870.3610
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Englewood, CO, US
Third-party review
No
Expedited review
No

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RecordFirmDate
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434)Biotronik, Inc.1999-11-10
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MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (K953417)Cook Pacemaker Corp.1995-09-29
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OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (K952364)Ela Medical, Inc.1995-09-01
PELLETHANE 75D (K940039)Medtronic Vascular1995-07-12
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CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. (P940024)Telectronics Pacing Systems, Inc.1997-07-03
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S032)Telectronics Pacing Systems, Inc.1990-05-09
SEQUICOR SERIES PULSE GEN. MODELS 233F,233G,& 240G (P820014/S044)Telectronics Pacing Systems, Inc.1990-05-09
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S030)Telectronics Pacing Systems, Inc.1990-03-22
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S042)Telectronics Pacing Systems, Inc.1990-03-22
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S031)Telectronics Pacing Systems, Inc.1990-02-02
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S043)Telectronics Pacing Systems, Inc.1990-02-02
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S041)Telectronics Pacing Systems, Inc.1989-04-18