Platinium VR 1210,1240 (ICD); Platinium DR 1510, 1540 (ICD)
FDA premarket approval P980049/S121 · decided 2016-09-07
Approval details
- PMA number
- P980049
- Supplement
- S121
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Platinium VR 1210,1240 (ICD); Platinium DR 1510, 1540 (ICD)
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2016-08-23
- Decision date
- 2016-09-07
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Change to the execution sequence for the final functional electrical test and the final functional test for radio frequency.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.