CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD
FDA premarket approval P830061/S119 · decided 2015-04-10
Approval details
- PMA number
- P830061
- Supplement
- S119
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-03-25
- Decision date
- 2015-04-10
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING TRANSFER OF THE SPACER-TIP TO RING COMPONENT TO A SUPPLIER.
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