PARADYM VR & DR
FDA premarket approval P980049/S070 · decided 2012-02-16
Approval details
- PMA number
- P980049
- Supplement
- S070
- Supplement type
- 30-Day Notice
- Trade name
- PARADYM VR & DR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2012-01-27
- Decision date
- 2012-02-16
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.