CapSure Sense Lead, Vitatron Crystalline Lead
FDA premarket approval P830061/S213 · decided 2023-05-26
Approval details
- PMA number
- P830061
- Supplement
- S213
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CapSure Sense 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
- 2023-02-28
- Decision date
- 2023-05-26
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval to remove one of the tip stiffness/pressure product design requirements from your internal standard on silicone and polyurethane leads.
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