PMA P940031S075
- Device
- VIGOR DR/SR,DISCOVERY,MERIDIAN
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S075
- Product code
- LWP
- Decision date
- 2013-09-25
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
Current openFDA PMA Record#
- Device
- VIGOR DR/SR,DISCOVERY,MERIDIAN
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S075
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-09-25
- Decision code
- OK30
- Date received
- 2013-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.