- Device
- SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S127
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2006-09-21
- Decision code
- OK30
- Date received
- 2006-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SILICONE HYDROHONE MASK TOOL USED TO MANUFACTURE THE DEVICES.