- Device
- SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S135
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2006-11-09
- Decision code
- OK30
- Date received
- 2006-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO THE MANUFACTURING SOFTWARE USED TO INITIALIZE THE VICTORY FAMILY OF PACEMAKERS.