FDA.reportPublic FDA data

PMA P140033S059

Device
Tendril MRl
Applicant
ABBOTT MEDICAL
PMA number
P140033
Supplement
S059
Product code
LWP
Decision date
2020-06-18
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.

Current openFDA PMA Record#

Device
Tendril MRl
Applicant
ABBOTT MEDICAL
PMA number
P140033
Supplement
S059
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-06-18
Decision code
OK30
Date received
2020-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.