Anesthesiology
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- CardiovascularReview Panel
- MiscellaneousMiscellaneous
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- P100023ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)APWDPMA Approval
Show All 15 Submissions
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Boston Scientific Corp.
- Trade Name
- ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
- Generic Name
- Coronary drug-eluting stent
- Decision Date
- 4/22/2011
- Days to Decision
- 309 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval