- Device
- CAPSURE/VITATRON CRYSTALINE/EXCELLENCE PS+
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S066
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2011-11-18
- Decision code
- APPR
- Date received
- 2011-06-08
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.