PMA P160043S088
- Device
- Resolute Onyx
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S088
- Product code
- NIQ
- Decision date
- 2025-06-26
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- scaling up the batch size for drug formulation
Current openFDA PMA Record#
- Device
- Resolute Onyx
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S088
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2025-06-26
- Decision code
- OK30
- Date received
- 2025-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- scaling up the batch size for drug formulation