CAPSURE SENSE LEAD
FDA premarket approval P830061/S124 · decided 2015-12-16
Approval details
- PMA number
- P830061
- Supplement
- S124
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-12-04
- Decision date
- 2015-12-16
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- A CHANGE IN ENVIRONMENTAL MONITORING FROM MANUAL READINGS TO AN AUTOMATED SOFTWARE SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.