CAPSURE Z NOVUS/CAPSURE Z/CAPSURE SP/ CAPSURE SP NOVUS LEADS
FDA premarket approval P850089/S060 · decided 2009-01-09
Approval details
- PMA number
- P850089
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE Z NOVUS/CAPSURE Z/CAPSURE SP/ CAPSURE SP NOVUS LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-12-11
- Decision date
- 2009-01-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE STERILIZATION PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.