PMA P050046S006

Device
ACUITY STEERABLE
Applicant
Guidant Corp.
PMA number
P050046
Supplement
S006
Product code
NVY
Decision date
2010-01-15
Classification
Permanent Defibrillator Electrodes
Generic name
Permanent defibrillator electrodes
Approval order statement
ADDITION OF STERILIZATION HOOP RACKS.

Current openFDA PMA Record#

Device
ACUITY STEERABLE
Applicant
Guidant Corp.
PMA number
P050046
Supplement
S006
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2010-01-15
Decision code
OK30
Date received
2009-12-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF STERILIZATION HOOP RACKS.