PMA P960030S005

Device: PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS
Applicant: ABBOTT MEDICAL
PMA number: P960030
Supplement: S005
Product code: DTB
Decision date: 1999-08-26
Generic name: permanent pacemaker Electrode
Approval order statement: Approval for the Model 1336T Passive Plus(R) DX Endocardial, Steroid Eluting, Passive Fixation pacing lead. This device is indicated for permanent pacing and sensing of the ventricle when used with a compatible pulse generator.

Current openFDA PMA Record#

Device: PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS
Applicant: ABBOTT MEDICAL
PMA number: P960030
Supplement: S005
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 1999-08-26
Decision code: APPR
Date received: 1999-04-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Model 1336T Passive Plus(R) DX Endocardial, Steroid Eluting, Passive Fixation pacing lead. This device is indicated for permanent pacing and sensing of the ventricle when used with a compatible pulse generator.