SIMPSON CORONARY ATHEROCATH-GTO
FDA premarket approval P890043/S034 · decided 1999-10-12
Approval details
- PMA number
- P890043
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIMPSON CORONARY ATHEROCATH-GTO
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 1999-09-13
- Decision date
- 1999-10-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- The 30-Day Notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly.
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