VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II DR/VR
FDA premarket approval P980016/S195 · decided 2009-10-27
Approval details
- PMA number
- P980016
- Supplement
- S195
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II DR/VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-06-02
- Decision date
- 2009-10-27
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.