PARADYM RF VR
FDA premarket approval P980049/S095 · decided 2014-04-16
Approval details
- PMA number
- P980049
- Supplement
- S095
- Supplement type
- 30-Day Notice
- Trade name
- PARADYM RF VR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-03-24
- Decision date
- 2014-04-16
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGES FOR THE DEVICES (PLATFORM ZL102):1) ADDED EQUIPMENT COOLER STACKER/DE-STACKER USED IN THE ELECTRONIC SMD ASSEMBLY LINE;2) LASER WELDING PROCESS REWORK FOR VISUAL DEFECT ON CASE; AND3. PARADYM RF (ZL102), IN SOURCING OF RF MODULE MANUFACTURING
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.