CAPSURE SENSE LEAD, 4073, CAPSURE SENSE UNIPOLAR LEAD, CAPSURE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON CRYSTALI
FDA premarket approval P830061/S081 · decided 2012-11-19
Approval details
- PMA number
- P830061
- Supplement
- S081
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE LEAD, 4073, CAPSURE SENSE UNIPOLAR LEAD, CAPSURE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON CRYSTALI
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-10-22
- Decision date
- 2012-11-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS.
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