FDA 510(k) Application Details - K954714

Device Classification Name	Permanent Pacemaker Electrode   More FDA Info for this Device
510(K) Number	K954714
Device Name	Permanent Pacemaker Electrode
Applicant	PACESETTER, INC. 15900 VALLEY VIEW COURT P.O. BOX 9221 SYLMAR, CA 91342-3577 US Other 510(k) Applications for this Company
Contact	PAUL MASON 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	10/02/1995
Decision Date	02/01/1996
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review