PMA P880086S065

Device
TENDRIL/PASSIVE PLUS/AV PLUS DX
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S065
Product code
DXY
Decision date
1999-11-10
Classification
Implantable Pacemaker Pulse-generator
Generic name
implantable pacemaker Pulse-generator
Approval order statement
Approval for the use of two alternate medical adhesives.

Current openFDA PMA Record#

Device
TENDRIL/PASSIVE PLUS/AV PLUS DX
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S065
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
1999-11-10
Decision code
APPR
Date received
1999-07-02
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the use of two alternate medical adhesives.