PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750; RF DR 9750; RF VR 9750; RF DR 9750; INTENSIA VR ICD, INTENSIA DR
FDA premarket approval P980049/S104 · decided 2014-12-16
Approval details
- PMA number
- P980049
- Supplement
- S104
- 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; RF DR 9750; RF VR 9750; RF DR 9750; INTENSIA VR ICD, INTENSIA DR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-11-21
- Decision date
- 2014-12-16
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- ADDITION OF A C-MODE SCANNING ACOUSTIC MICROSCOPY SYSTEM IN THE MANUFACTURING ASSEMBLY LINE.
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