Stellarex 0.035 OTW Drug-coated Angioplasty Ballon
FDA premarket approval P160049/S005 · decided 2019-05-03
Approval details
- PMA number
- P160049
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Stellarex 0.035 OTW Drug-coated Angioplasty Ballon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2019-04-08
- Decision date
- 2019-05-03
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Extension of the drug substance retest period and modification of heavy metals testing requirements.
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