PMA P910020S010

Device
RELAY/DASH/STRIDE/DART PACING SYSTEMS
Applicant
Boston Scientific
PMA number
P910020
Supplement
S010
Product code
DXY
Decision date
1996-03-15
Generic name
implantable pacemaker Pulse-generator
Approval order statement
ALTERNATE ACCELEROMETER

Current openFDA PMA Record#

Device
RELAY/DASH/STRIDE/DART PACING SYSTEMS
Applicant
Boston Scientific
PMA number
P910020
Supplement
S010
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
1996-03-15
Decision code
APPR
Date received
1995-08-29
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
ALTERNATE ACCELEROMETER