CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592
FDA premarket approval P830061/S128 · decided 2016-04-12
Approval details
- PMA number
- P830061
- Supplement
- S128
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-03-17
- Decision date
- 2016-04-12
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Addition of a new laser welding machine.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.