CONSULTA CRT-P, SYNCRA CRT-P
FDA premarket approval P010015/S233 · decided 2014-02-27
Approval details
- PMA number
- P010015
- Supplement
- S233
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA CRT-P, SYNCRA CRT-P
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2014-01-31
- Decision date
- 2014-02-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODIFYING THE START AND END POSITION OF THE WELD SEQUENCE, CORRECTING A SYNCHRONIZATION ISSUE IN THE EQUIPMENT PROGRAM, AND MODIFYING THE ASSOCIATED WORK INSTRUCTIONS FOR THE MIDDLE BRACKET USED WITH THE DEVICES.
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