PMA P980049S134
- Device
- Implantable Cardioverter Defibrillator ICDs
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S134
- Product code
- MRM
- Decision date
- 2019-03-05
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Addition of a pre-conditioning step prior to the Electrical Wafer Sorting test.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillator ICDs
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S134
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2019-03-05
- Decision code
- OK30
- Date received
- 2019-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a pre-conditioning step prior to the Electrical Wafer Sorting test.