PMA P940031S078
- Device
- Accessory Kit
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S078
- Product code
- DXY
- Decision date
- 2019-04-08
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.
Current openFDA PMA Record#
- Device
- Accessory Kit
- Applicant
- Boston Scientific
- PMA number
- P940031
- Supplement
- S078
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2019-04-08
- Decision code
- OK30
- Date received
- 2019-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.