Platinium VR 1210; Platinium VR 1240; Platinium DR 1510; Platinium DR 1540
FDA premarket approval P980049/S116 · decided 2016-08-08
Approval details
- PMA number
- P980049
- Supplement
- S116
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Platinium VR 1210; Platinium VR 1240; Platinium DR 1510; Platinium DR 1540
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2016-07-14
- Decision date
- 2016-08-08
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Use of the Automated Optical Inspection equipment during the microelectronic and electronic assembly manufacturing.
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