MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II
FDA premarket approval P980016/S305 · decided 2011-11-10
Approval details
- PMA number
- P980016
- Supplement
- S305
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-06-09
- Decision date
- 2011-11-10
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADDITION OF A CLEANING PROCESS AT THE SUPPLIER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.