ICDs (Implantable Cardioverter Defibrillator) Platinium VR 1210, 1240; Platinium DR 1510, 1540.
FDA premarket approval P980049/S122 · decided 2016-09-21
Approval details
- PMA number
- P980049
- Supplement
- S122
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ICDs (Implantable Cardioverter Defibrillator) Platinium VR 1210, 1240; Platinium DR 1510, 1540.
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2016-08-23
- Decision date
- 2016-09-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Alternate manufacturing flow sequence, the addition of new dispensing equipment and an optional step in the manufacturing line for the microelectronic and electronic assembly.
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