PMA P880086S064

Device: ADDVENT/AV PLUS DX
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S064
Product code: DXY
Decision date: 1999-07-23
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for an extension of the approved shelf life for the device including pulse generator Models 2060BL and 2060LR (12 to 18 months), and the Model 1368 Single Pass Lead (12 to 24 months).

Current openFDA PMA Record#

Device: ADDVENT/AV PLUS DX
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S064
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1999-07-23
Decision code: APPR
Date received: 1999-07-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an extension of the approved shelf life for the device including pulse generator Models 2060BL and 2060LR (12 to 18 months), and the Model 1368 Single Pass Lead (12 to 24 months).