PMA P830026S080
- Device
- COSMOS
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S080
- Product code
- LWP
- Decision date
- 2012-04-23
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
Current openFDA PMA Record#
- Device
- COSMOS
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S080
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-04-23
- Decision code
- OK30
- Date received
- 2012-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.