CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-D
FDA premarket approval P010031/S361 · decided 2014-04-23
Approval details
- PMA number
- P010031
- Supplement
- S361
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-02-21
- Decision date
- 2014-04-23
- Days to decision
- 426 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS(HANGZHOU) CO., LTD., IN HANGZHOU, ZHEJIANG, CHINA.
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