CHANGES TO PINKERTON & OMEGA CORO.DIL. CATHETERS
FDA premarket approval P810046/S126 · decided 1993-07-21
Approval details
- PMA number
- P810046
- Supplement
- S126
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CHANGES TO PINKERTON & OMEGA CORO.DIL. CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1992-06-09
- Decision date
- 1993-07-21
- Days to decision
- 407 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
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