PMA P050046S015

Device
ACUITY STEERABLE IMPLANTABLE LEADS
Applicant
Guidant Corp.
PMA number
P050046
Supplement
S015
Product code
NVY
Decision date
2012-08-27
Classification
Permanent Defibrillator Electrodes
Generic name
Permanent defibrillator electrodes
Approval order statement
ADDITIONAL SUPPLIER FOR A LEAD COMPONENT.

Current openFDA PMA Record#

Device
ACUITY STEERABLE IMPLANTABLE LEADS
Applicant
Guidant Corp.
PMA number
P050046
Supplement
S015
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2012-08-27
Decision code
OK30
Date received
2012-07-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITIONAL SUPPLIER FOR A LEAD COMPONENT.