PARADYM CRT-D 8750,PARADYM RF CRT-D9750
FDA premarket approval P060027/S059 · decided 2014-02-27
Approval details
- PMA number
- P060027
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADYM CRT-D 8750,PARADYM RF CRT-D9750
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-01-29
- Decision date
- 2014-02-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGE RELATED TO THE LASER WELDING PROCESS REWORK FOR A VISUAL DEFECT APPLICABLE TO THESE IMPLANTABLE PULSE GENERATORS.
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