PMA P840068S033

Device
DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
Applicant
Boston Scientific
PMA number
P840068
Supplement
S033
Product code
LWP
Decision date
1997-08-08
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).

Current openFDA PMA Record#

Device
DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
Applicant
Boston Scientific
PMA number
P840068
Supplement
S033
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1997-08-08
Decision code
APPR
Date received
1997-07-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).