Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's
FDA premarket approval P980049/S119 · decided 2016-09-07
Approval details
- PMA number
- P980049
- Supplement
- S119
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2016-08-09
- Decision date
- 2016-09-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for Platinium embedded software version 2.4.2.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.