CAPSURE SENSE BIPOLAR LEAD
FDA premarket approval P830061/S064 · decided 2012-10-04
Approval details
- PMA number
- P830061
- Supplement
- S064
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE BIPOLAR LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-05-05
- Decision date
- 2012-10-04
- Days to decision
- 518 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE PTE. LTD, IN SINGAPORE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.