PMA P110019S049
- Device
- XIENCE PRIME EECSS (XIENCE PRIME AND XIENCE PRIME LONG LENGTHS [LL])
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S049
- Product code
- NIQ
- Decision date
- 2013-06-27
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE TO THE APHA COLOR TEST METHOD FOR A SOLVENT USED IN THE MANUFACTURING OF AV¿S DEVICE-DRUG COMBINATION PRODUCTS.
Current openFDA PMA Record#
- Device
- XIENCE PRIME EECSS (XIENCE PRIME AND XIENCE PRIME LONG LENGTHS [LL])
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S049
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-06-27
- Decision code
- OK30
- Date received
- 2013-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE APHA COLOR TEST METHOD FOR A SOLVENT USED IN THE MANUFACTURING OF AV¿S DEVICE-DRUG COMBINATION PRODUCTS.