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FDA 510(k) Application Details - K000029
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
510(K) Number
K000029
Device Name
Permanent Pacemaker Electrode
Applicant
ELA MEDICAL, INC.
2950 XENIUM LN. NORTH
PLYMOUTH, MN 55441 US
Other 510(k) Applications for this Company
Contact
CATHERINE G GOBLE
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
DTB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/05/2000
Decision Date
04/04/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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