CAPSURE/CAPSURE SP/CAPSURE SP NOVUS/CAPSURE SENSE/VITATRON EXCELLENCE +/PS+/CRYSTALLINE
FDA premarket approval P830061/S045 · decided 2009-03-06
Approval details
- PMA number
- P830061
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE/CAPSURE SP/CAPSURE SP NOVUS/CAPSURE SENSE/VITATRON EXCELLENCE +/PS+/CRYSTALLINE
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-02-05
- Decision date
- 2009-03-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.