PMA P880086S056

Device
TRILOGY FAMILY OF PULSE GENERATORS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S056
Product code
DXY
Decision date
1998-11-03
Classification
Implantable Pacemaker Pulse-generator
Generic name
implantable pacemaker Pulse-generator
Approval order statement
Approval for a change in the insulating ring surrounding the negative pin of the battery in Trilogy pacers.

Current openFDA PMA Record#

Device
TRILOGY FAMILY OF PULSE GENERATORS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S056
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
1998-11-03
Decision code
APPR
Date received
1998-10-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change in the insulating ring surrounding the negative pin of the battery in Trilogy pacers.