PMA P830060S045

Device
STYLET ACCESSORY KIT
Applicant
Boston Scientific
PMA number
P830060
Supplement
S045
Product code
LWS
Decision date
2000-01-19
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Supplemental approval is for the stylet accessory kit Models 6983 and 6985.

Current openFDA PMA Record#

Device
STYLET ACCESSORY KIT
Applicant
Boston Scientific
PMA number
P830060
Supplement
S045
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2000-01-19
Decision code
APPR
Date received
1999-08-25
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Supplemental approval is for the stylet accessory kit Models 6983 and 6985.