PMA P830061S053
- Device
- CAPSURE SP/SP NOVUS LEADS/CAPSURE SENSE/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS +/+
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S053
- Product code
- NVY
- Decision date
- 2010-08-13
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
Current openFDA PMA Record#
- Device
- CAPSURE SP/SP NOVUS LEADS/CAPSURE SENSE/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS +/+
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S053
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2010-08-13
- Decision code
- OK30
- Date received
- 2010-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.