CapSure Sense Lead, SP Novus Lead; Vitron Crystalline Lead
FDA premarket approval P830061/S164 · decided 2018-11-19
Approval details
- PMA number
- P830061
- Supplement
- S164
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure Sense Lead, SP Novus Lead; Vitron Crystalline Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-10-23
- Decision date
- 2018-11-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for a new manufacturing site and the addition of a new mold press at external supplier FMI, Inc
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.