CONSULTA CRT-P, SYNCRA CRT-P
FDA premarket approval P010015/S235 · decided 2014-04-04
Approval details
- PMA number
- P010015
- Supplement
- S235
- 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
- 2014-03-07
- Decision date
- 2014-04-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING PROCESS CHANGE FOR THE PRINTED WIRING BOARD (PWB) SUBSTRATES AT A MEDTRONIC SECOND TIER SUPPLIER. THESE PWB SUBSTRATES ARE USED IN THE MANUFACTURE OF HYBRID SUBSTRATES AT MEDTRONIC¿S INTERNAL SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), FOR THE DEVICES.
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