PMA P040040S035
- Device
- AMPLATZER Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S035
- Product code
- MLV
- Decision date
- 2019-03-05
- Classification
- Transcatheter Septal Occluder
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Approval for an alternate sterilization site located at Sterigenics, 5725 Harold Gatty Drive, Salt Lake City, Utah.
Current openFDA PMA Record#
- Device
- AMPLATZER Muscular VSD Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040040
- Supplement
- S035
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2019-03-05
- Decision code
- APPR
- Date received
- 2019-02-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate sterilization site located at Sterigenics, 5725 Harold Gatty Drive, Salt Lake City, Utah.