ACS OTW PHOTON CORONARY DILATATION CATHETER
FDA premarket approval P810046/S199 · decided 1999-10-29
Approval details
- PMA number
- P810046
- Supplement
- S199
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACS OTW PHOTON CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1999-10-08
- Decision date
- 1999-10-29
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- The 30-Day Notice requested: 1) modification of the manufacturing process by which the proximal adapter is bonded to the proximal portion of the ACS OTW PHOTON(TM) Coronary Dilatation Catheter; and 2) modification of the adaptation tensile test at the finished device audit process.
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