PMA P840068S029
- Device
- VIGOR MODEL 2880 SOFTWARE APPLICATION
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S029
- Product code
- LWP
- Decision date
- 1996-11-07
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- 1)NEW PROGRAMMING SYSTEM, WITH MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2)A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987
Current openFDA PMA Record#
- Device
- VIGOR MODEL 2880 SOFTWARE APPLICATION
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S029
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-11-07
- Decision code
- APPR
- Date received
- 1996-03-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 1)NEW PROGRAMMING SYSTEM, WITH MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2)A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987