PARADYM RF CRT-D
FDA premarket approval P060027/S041 · decided 2012-05-30
Approval details
- PMA number
- P060027
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Trade name
- PARADYM RF CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2012-05-16
- Decision date
- 2012-05-30
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- THE FOLLOWING CHANGES: 1) AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER; 2) AN UPDATE TO THE REWORK PROCESS; 3) IN-SOURCING OF AN ELECTRONIC ASSEMBLY; 4) CLEAN ROOM LAYOUT MODIFICATION AT SALUGGIA, ITALY, PLANT, AND; 5)AN ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.
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