Paradym and Paradym RF, Update to Platinium Embedded Software
FDA premarket approval P980049/S125 · decided 2017-07-26
Approval details
- PMA number
- P980049
- Supplement
- S125
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Paradym and Paradym RF, Update to Platinium Embedded Software
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2017-05-22
- Decision date
- 2017-07-26
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for updates to the embedded software and programmer module software.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.