- Device
- PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S264
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-05-10
- Decision code
- OK30
- Date received
- 2021-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.