- Device
- CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S098
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-04-20
- Decision code
- APPR
- Date received
- 2005-12-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MANUFACTURING TEST SOFTWARE AND MANUFACTURING PROCESS SEQUENCES.