SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS
FDA premarket approval P980016/S239 · decided 2010-06-03
Approval details
- PMA number
- P980016
- Supplement
- S239
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-05-07
- Decision date
- 2010-06-03
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN LOCATION FOR A SUPPLIER OF ZENER DIODES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.