PMA P830061S094
- Device
- CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCLLENCE PS+ LEAD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S094
- Product code
- NVY
- Decision date
- 2013-06-19
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
Current openFDA PMA Record#
- Device
- CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCLLENCE PS+ LEAD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S094
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2013-06-19
- Decision code
- OK30
- Date received
- 2013-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.