Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room
FDA premarket approval P960040/S492 · decided 2023-05-01
Approval details
- PMA number
- P960040
- Supplement
- S492
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2023-04-24
- Decision date
- 2023-05-01
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add a new Controlled Environment Area (CEA) Level VIII and a new CEA Level IX for pulse generator and implantable cardiac monitor battery manufacturing.
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