CORONARY DILATATION CATHETERS
FDA premarket approval P810046/S240 · decided 2010-10-15
Approval details
- PMA number
- P810046
- Supplement
- S240
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORONARY DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2010-09-17
- Decision date
- 2010-10-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- CHANGE TO THE METHODOLOGY FOR STERILIZATION DOSE AUDITS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.