PMA P030054S066

Device
CRT-D'S
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S066
Product code
NIK
Decision date
2007-09-28
Classification
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
ALTERNATE PROCESS TO REMOVE CLEANING AND FINISHING RESIDUE FROM DEVICES FOLLOWING SODA BLAST AND GRIT BLAST PROCESS.

Current openFDA PMA Record#

Device
CRT-D'S
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S066
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2007-09-28
Decision code
OK30
Date received
2007-08-30
Supplement type
30-Day Notice
Approval order statement
ALTERNATE PROCESS TO REMOVE CLEANING AND FINISHING RESIDUE FROM DEVICES FOLLOWING SODA BLAST AND GRIT BLAST PROCESS.