CAPSURE SP NOVUS LEAD, VITATRON EXCELLENCE PS+ LEAD
FDA premarket approval P830061/S111 · decided 2014-08-12
Approval details
- PMA number
- P830061
- Supplement
- S111
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SP NOVUS LEAD, VITATRON EXCELLENCE PS+ LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-07-14
- Decision date
- 2014-08-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- TRANSFER OF COMPONENT MANUFACTURING TO A DIFFERENT INTERNAL SUPPLIER FOR THE TWO MCRD (MONOLITHIC CONTROLLED RELEASE DEVICE) COMPONENTS USED IN THE CARDIAC LEAD MODELS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.