PARADYM (VR/DR) 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF (VR/DR) 9750,INTENSIA (VR 124/DR 154)
FDA premarket approval P980049/S107 · decided 2015-03-13
Approval details
- PMA number
- P980049
- Supplement
- S107
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADYM (VR/DR) 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF (VR/DR) 9750,INTENSIA (VR 124/DR 154)
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2015-02-19
- Decision date
- 2015-03-13
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- USE OF ADDITIONAL ELECTRICAL WELDING EQUIPMENT IN THE MANUFACTURING LABORATORY.
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