PMA P980049S110
- Device
- PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101,ZL102))
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S110
- Product code
- MRM
- Decision date
- 2015-07-31
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- ADDITIONAL REFLOW OVEN AND A MODIFICATION IN THE REFLOW OVEN QUALIFICATION METHOD.
Current openFDA PMA Record#
- Device
- PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101,ZL102))
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S110
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2015-07-31
- Decision code
- OK30
- Date received
- 2015-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL REFLOW OVEN AND A MODIFICATION IN THE REFLOW OVEN QUALIFICATION METHOD.