PMA P830026S081
- Device
- COSMOS
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S081
- Product code
- LWP
- Decision date
- 2012-12-05
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
Current openFDA PMA Record#
- Device
- COSMOS
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S081
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-12-05
- Decision code
- OK30
- Date received
- 2012-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE TRACEABILITY AND TRACKING SYSTEM.