PMA P010012S231
- Device
- CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S231
- Product code
- LWP
- Decision date
- 2010-01-12
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S231
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2010-01-12
- Decision code
- OK30
- Date received
- 2009-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.