ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II
FDA premarket approval P980016/S297 · decided 2011-05-19
Approval details
- PMA number
- P980016
- Supplement
- S297
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-04-26
- Decision date
- 2011-05-19
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
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