PARADYM VR 8750, PARADYM DR8750
FDA premarket approval P980049/S083 · decided 2013-08-13
Approval details
- PMA number
- P980049
- Supplement
- S083
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADYM VR 8750, PARADYM DR8750
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-07-15
- Decision date
- 2013-08-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- ADDITION OF NON-FUNCTIONAL STRUCTURES WITHIN THE METAL LAYERS AND THEMODIFICATION OF THE VISUAL INSPECTION PROCESS FOR INTEGRATED CIRCUITS IN THE IMPLANTABLE PULSE GENERATORS.
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