PMA P830026S075

Device
RX5000 PROGRAMMER
Applicant
Boston Scientific
PMA number
P830026
Supplement
S075
Product code
LWP
Decision date
1999-09-24
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for a manufacturing site located at Benchmark Electronics, 4065 Theurer Blvd., Winona, MN 55987.

Current openFDA PMA Record#

Device
RX5000 PROGRAMMER
Applicant
Boston Scientific
PMA number
P830026
Supplement
S075
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1999-09-24
Decision code
APPR
Date received
1999-09-07
Supplement type
Normal 180 Day Track
Supplement reason
Express GMP Supplement
Approval order statement
Approval for a manufacturing site located at Benchmark Electronics, 4065 Theurer Blvd., Winona, MN 55987.