BRAVA/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT ,VIVA QUAD S/XT/S CRT-D'S
FDA premarket approval P010031/S454 · decided 2014-07-22
Approval details
- PMA number
- P010031
- Supplement
- S454
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT ,VIVA QUAD S/XT/S CRT-D'S
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-07-15
- Decision date
- 2014-07-22
- Days to decision
- 7 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODIFICATION ON LASER SEAM WELDER EQUIPMENT AT A FINAL DEVICE MANUFACTURING FACILITY FOR THE DEVICES.
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