SELECTSECURE LEAD
FDA premarket approval P030036/S076 · decided 2015-02-07
Approval details
- PMA number
- P030036
- Supplement
- S076
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELECTSECURE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-01-21
- Decision date
- 2015-02-07
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SECOND SOURCE SUPPLIER FOR FIVE LEAD COMPONENTS (SCREW-IN CONNECTOR RING, ROTATING CONNECTOR PIN, CF-1 ELECTRODE PIN, SCREW-IN CONNECTOR RING, AND FOUR POLE LEAD CONNECTOR RING) USED IN THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.