CAPSURE/CAPSURE Z NOVUS/STERX TIP PACING LEAD (VENTRICULAR)/VITATRON EXCELLENCE S+/EXCELLENCE SS+/IMPULSE/IMPULSE II
FDA premarket approval P850089/S065 · decided 2010-04-28
Approval details
- PMA number
- P850089
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE/CAPSURE Z NOVUS/STERX TIP PACING LEAD (VENTRICULAR)/VITATRON EXCELLENCE S+/EXCELLENCE SS+/IMPULSE/IMPULSE II
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-03-29
- Decision date
- 2010-04-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION 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.