ALAIR BRONCHIAL THERMOPLASTY SYSTEM
FDA premarket approval P080032/S009 · decided 2012-06-26
Approval details
- PMA number
- P080032
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Generic name
- Bronchial thermoplasty system
- Applicant
- Boston Scientific Corp
- Date received
- 2012-02-14
- Decision date
- 2012-06-26
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- OOY
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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