PMA P150033S157
- Device
- Micra
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S157
- Product code
- PNJ
- Decision date
- 2022-11-01
- Generic name
- Leadless pacemaker
- Approval order statement
- Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.
Current openFDA PMA Record#
- Device
- Micra
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S157
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2022-11-01
- Decision code
- OK30
- Date received
- 2022-10-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.