PMA P010012S143

Device
CONTAK RENEWAL FAMILY
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S143
Product code
LWP
Decision date
2006-12-06
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.

Current openFDA PMA Record#

Device
CONTAK RENEWAL FAMILY
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S143
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2006-12-06
Decision code
OK30
Date received
2006-11-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.