CONSULTA CRT-P, SYNCRA CTR-P
FDA premarket approval P010015/S282 · decided 2015-10-22
Approval details
- PMA number
- P010015
- Supplement
- S282
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA CRT-P, SYNCRA CTR-P
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2015-09-30
- Decision date
- 2015-10-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) TO FACTORY WORKS 9.1, IMPM MES WEB SERVICES 3.0.0, AND OTHER ASSOCIATED CHANGES.
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