PMA P050046S004

Device
ACUITY STEERABLE LEAD
Applicant
Guidant Corp.
PMA number
P050046
Supplement
S004
Product code
NVY
Decision date
2009-06-26
Classification
Permanent Defibrillator Electrodes
Generic name
Permanent defibrillator electrodes
Approval order statement
APPROVAL OF A NEW PULL TESTER.

Current openFDA PMA Record#

Device
ACUITY STEERABLE LEAD
Applicant
Guidant Corp.
PMA number
P050046
Supplement
S004
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2009-06-26
Decision code
APPR
Date received
2009-02-04
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL OF A NEW PULL TESTER.