PMA P220003S017
- Device
- PASCAL Precision Implant System, PASCAL Precision Guide Sheath
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S017
- Product code
- NKM
- Decision date
- 2024-07-30
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- the addition of a new ethylene oxide (EO) sterilization cycle to reduce the EO gas concentration
Current openFDA PMA Record#
- Device
- PASCAL Precision Implant System, PASCAL Precision Guide Sheath
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S017
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2024-07-30
- Decision code
- OK30
- Date received
- 2024-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a new ethylene oxide (EO) sterilization cycle to reduce the EO gas concentration