CapSure Epicardial Pacing Lead
FDA premarket approval P950024/S086 · decided 2019-07-02
Approval details
- PMA number
- P950024
- Supplement
- S086
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure Epicardial Pacing Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2019-06-21
- Decision date
- 2019-07-02
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Transfer electrode assemblies from the Medtronic Energy and Component Center facility to the Medtronic Rice Creek and Medtronic Puerto Rico Operations Company facilities for completion and final inspection.
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