PMA P950001S011

Device
SELUTE,SELUTE PICOTIP
Applicant
Boston Scientific
PMA number
P950001
Supplement
S011
Product code
DTB
Decision date
2004-05-14
Generic name
permanent pacemaker Electrode
Approval order statement
CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.

Current openFDA PMA Record#

Device
SELUTE,SELUTE PICOTIP
Applicant
Boston Scientific
PMA number
P950001
Supplement
S011
Product code
DTB
Generic name
permanent pacemaker Electrode
Decision date
2004-05-14
Decision code
OK30
Date received
2004-04-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.