- Device
- CONTAK RENEWAL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S066
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-11-24
- Decision code
- APPR
- Date received
- 2005-08-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE USE OF FOUR NEW INNER LEAD BONDING (ILB) MACHINES ON THE TAPE AUTOMATED BONDING (TAB) MANUFACTURING LINE FOR PULSE GENERATORS.