FDA PMA
30-Day Notice Accepted
🇺🇸 United States
PMA: P010031
·
Supplement: S209
·
Decision Aug 13, 2010
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- INSYNC SENTRY & INSYNC MAXIMO
- PMA Number
- P010031
- Supplement Number
- S209
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 13, 2010
- Date Received
- July 15, 2010
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.