PMA P940031
- Device
- VIGOR DR/SR, DISCOVERY, and MERIDIAN
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S079
- Product code
- DXY
- Decision date
- 2021-04-02
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Implement the Global Labeling System version 3.0 at select locations.
Current openFDA PMA Record#
- Device
- VIGOR DR/SR, DISCOVERY, and MERIDIAN
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S079
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2021-04-02
- Decision code
- OK30
- Date received
- 2021-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the Global Labeling System version 3.0 at select locations.