PMA P040021S048
- Device
- Biocor™, Biocor™ Supra, Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S048
- Product code
- LWR
- Decision date
- 2021-12-16
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Discontinuation of passive monitoring procedures in ISO Class 7 and 8 cleanrooms.
Current openFDA PMA Record#
- Device
- Biocor™, Biocor™ Supra, Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S048
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-12-16
- Decision code
- OK30
- Date received
- 2021-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Discontinuation of passive monitoring procedures in ISO Class 7 and 8 cleanrooms.