PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR
FDA premarket approval P980049/S106 · decided 2015-03-17
Approval details
- PMA number
- P980049
- Supplement
- S106
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2015-02-18
- Decision date
- 2015-03-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- ADDITION OF AUTOMATED OPTICAL INSPECTION (AOI) IN MANUFACTURING ASSEMBLY LINE FOR THE DEVICES.
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