CapSure Sense Lead, Vitatron Crystalline Lead
FDA premarket approval P830061/S203 · decided 2022-03-14
Approval details
- PMA number
- P830061
- Supplement
- S203
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2022-02-16
- Decision date
- 2022-03-14
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Modification to the electrode coating inspection process at Medtronic's supplier-Heraeus located in Hanau, Germany.
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