FDA.reportPublic FDA data

PMA P880086S038

Device
ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S038
Product code
DXY
Decision date
1999-05-13
Classification
Implantable Pacemaker Pulse-generator
Generic name
implantable pacemaker Pulse-generator
Approval order statement
Approval for the AddVent(R) VDDR Pacing System consisting of Models 2060BL and 2060LR pulse generators and the AV Plus(R) Model 1368 single-pass lead. The indications are specified in Attachment A.

Current openFDA PMA Record#

Device
ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S038
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
1999-05-13
Decision code
APPR
Date received
1996-08-12
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the AddVent(R) VDDR Pacing System consisting of Models 2060BL and 2060LR pulse generators and the AV Plus(R) Model 1368 single-pass lead. The indications are specified in Attachment A.