PMA P150036S052
- Device
- EDWARDS INTUITY Elite Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S052
- Product code
- LWR
- Decision date
- 2020-09-07
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Modifications in cleanroom entry pathways and shifting manufacturing lines between cleanrooms for improved operational efficiency.
Current openFDA PMA Record#
- Device
- EDWARDS INTUITY Elite Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S052
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-09-07
- Decision code
- OK30
- Date received
- 2020-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications in cleanroom entry pathways and shifting manufacturing lines between cleanrooms for improved operational efficiency.