CapSure Sense Lead; CapSure SP Novus Lead; Vitatron Crystalline Lead
FDA premarket approval P830061/S161 · decided 2018-07-12
Approval details
- PMA number
- P830061
- Supplement
- S161
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure Sense Lead; CapSure SP Novus Lead; Vitatron Crystalline Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-06-20
- Decision date
- 2018-07-12
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Process improvement at the supplier to automate the ball tipping process of the stylet wires.
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